MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for SCALPEL 32.1*1.2 F/PIEZOELECTRIC SYSTEM 03.000.423S manufactured by Depuy Synthes Products Llc.
[110332377]
Udi: the lot number is unknown and the gtin is unavailable. The product was made prior to compliance date. Therefore, udi is unavailable. (b)(6). The manufacturing location was unknown. The lot number was unknown; therefore, the device manufacture date is unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[110332378]
This is report 2 of 3 for the same event: it was reported from (b)(6) that during rhinoplasty, it was observed that there was de-epithelization of the skin on the left side of the nose while using the saw device to take down the dorsal hump. According to the reporter, the saw device was being used with the irrigation tubing device that appeared to be working appropriately. It was further reported that long scalpel devices were also used at the time of the event. It was reported that the surgeon was very surprised that there was a soft tissue injury that resulted in a full thickness burn on the side of the nose given that the saw device would only work in contact with mineralized bone. The surgeon reported that he was using the burr with the transverse saw device for reducing the dorsum and thought that the end of the saw device appeared to have caused the burn to the skin. As a result, the patient ended up with a burn scarring and would require a second operation. The reporter stated that the piezo saw device was used as part of a rhinoplasty to reduce the dorsal hump and to carry out the lateral osteotomies. There was no other procedure than the rhinoplasty. It was further reported that the surgery was not prolonged because of this event as the burn was noted quite later on in the procedure. The surgeon further reiterated that it was difficult at this stage to know the degree of recovery that could be expected as it would certainly require monitoring over the next two years and a revision surgery. According to the surgeon, the patient? S current condition was that they had a burnt scar on the left side of their nose, which was dark, thin, atrophic and extremely noticeable. In that regard, there was a severe permanent and lasting impact to the patient. The surgeon further stated that, they were in the process of managing the patient? S scar and the patient would have to undergo a scar revision at some point in the future. It was further reported that at the time of the surgery, there was nothing unusual about the saw function, the saw pieces or the efficacy of the saw in treating the osteotomy or the dorsal hump. It was not reported if a spare device was available for use. There was patient involvement reported. There was patient harm that resulted in a medical intervention and prolonged hospitalization. Upon further follow up with the reporter, it was discovered that the surgeon performed a revision surgery on the patient on (b)(6) 2018. The patient? S outcome was not yet known. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[112058943]
During subsequent follow-up with the customer additional information was obtained. The reporter stated that the procedure chosen for the rhinoplasty was an open approach. It was further reported that the patient recently had a revision surgery which was in the early stages. It was reported that it currently looked as though the depressed element of the scar was much improved; however, the scar was still at this stage, young, a little red and inflamed. The reporter indicated that they believed it would take at least six months before they were able to comment on how significant the improvement had been. Lot number and device manufacture date: the device lot number was not available in the initial report. Therefore, the lot number and manufacture date were documented as unknown. The lot number has been identified as 0871874. The device manufacture date has been updated to 12/9/2016. The manufacturer location was documented as unknown in the initial report. The location has been updated to depuy synthes supplier. Gtin is unavailable as the product made prior to compliance date. However, the udi has been updated accordingly based on the available product information. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[113790510]
Additional information: describe event or problem: the medical adviser followed up with the surgeon and additional information was obtained. The surgeon reported that the patient was a (b)(6) female whom underwent an elective rhinoplasty. The surgeon felt that the piezo system was revolutionising that type of surgery, as he had been impressed at the ability to reduce the dorsal hump. The surgeon reported that many surgeons were now switching to this system. It was further reported that the lesion was a full thickness burn on the left side of the nose, lateral to the dorsal hump. That was managed as full thickness burn and left to eschar. Over the following months the eschar resulted a prominent scalloping of the left side of the nose and the patient underwent a second procedure. The surgeon reported not having been on a formal training cadaveric based course for the instrument, but, had been to a number of symposia where? (b)(6)? Had spoken positively about it and he undertook his first case under the observation of the depuy synthes representative. He reported that the patient was his second case. According to the surgeon, getting each procedural step was not possible. He reported having to make a slightly larger incision than for traditional methods, but, was happy to do so due to the good reduction in the dorsal hump it provided. He dissected down and flared open the soft tissues. Then he used a continuous sweeping motion to shave down the dorsal hump and used continuous irrigation whilst to do so. It was further reported that the injury occurred while using the device to shave the dorsal hump. The surgeon further reported that he believed he used the smaller scalpel tip for the removal of the dorsal hump. The surgeon when on to explain which step and with which tip the burn happened. He reported that he shaved the dorsal hump by moving the instrument (407s) back and forth until desired reduction was achieved and while he was doing this, he noticed smoke coming from the soft tissue (like diathermy smoke) from the side of the dorsal hump. It was reported that its then that he noticed the full thickness of the burn in the left side of the nasal soft tissue. The surgeon reported that there was no obvious reduction in irrigation flow or cessation of irrigation. He queried whether despite the saw being in direct contact with bone, if the edge of the tip was in contact with soft tissue could a burn be caused because of; (a)mechanical vibration of the tip against the skin, (b) heating up of the tip which may be in contact with soft tissue and, (c) irrigation doesn? T run sufficiently into the periphery where the scalpel tip may be in contact with soft tissue. Regarding the amount of liquid used for each step, it was reported that the surgeon was unable to quantify as they did not measure how much fluid was used during the surgery. According to the reporter, the records of procedure was not able to be viewed as notes at another hospital; therefore, they were unable to quantify the flow rate of the irrigation (that was unlikely to be recorded). The surgeon reported that he reported no obvious reduction or noticeable issue with the irrigation which he reported using continuously. The surgeon reported that the tips had been used once as they had them as single use instruments. It was reported that the devices were not available for investigation because they had been disposed of and not possible to retrieve. The surgeon was pragmatic that without the device / tip it was not possible to know if it was used in error, or, if there was an issue with that tip. He reported that he continued to use the hand device and had no issues. He had also had no further issues while using those tips; although he had now become selective with which patients he uses the device with, due to this experience. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2018-54139 |
| MDR Report Key | 7576468 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-08 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES SUPPLIER |
| Manufacturer Street | N/I |
| Manufacturer City | N/I |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCALPEL 32.1*1.2 F/PIEZOELECTRIC SYSTEM |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2018-06-06 |
| Catalog Number | 03.000.423S |
| Lot Number | 0871874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |