MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-12-04 for BONECUTTER OSTEOTOME HANDSET OHB300/2 manufactured by Orthofix Srl.
[129781911]
In july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. (item involved in this event was manufactured by orthosonics ltd). Technical evaluation: the device involved in this event was received by orthofix (b)(4) on november 21, 2018. The technical evaluation is ongoing. Medical evaluation: the information made available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation become available. As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129781912]
The information provided by the local distributor indicates: hospital name: (b)(6); surgeon's name: dr. (b)(6); date of initial surgery: (b)(6) 2018; body part to which device was applied: hip; surgery description: arthroplasty revision; patient's information: female ; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description provided by sales rep: we used the flat osteotome probe to make initial slots at the head of the stem. Dr (b)(6) explained there was significant bone ingrowth around the head of the stem and wanted to remove this. The handpiece was working perfectly for this section and we encountered zero problems. Following this dr. (b)(6) used manual osteotome's to clear a pathway to use the silver (cemented handpiece). We then attached the flat piercer probe to make slots around the cemented stem. Once the stem was removed, dr (b)(6) attached the 8mm scraper probe to remove the remaining layers of the cement in the canal. Dr. (b)(6) then spent a significant amount of time trying to remove the uncemented acetabular cup. Stryker has a new system to remove this uncemented cup, so he wanted to trial this new system. This then failed and i suggested to use our gold handpiece with the 6mm curved serrated osteotome probe. I first encountered an issue when generator displayed the message "poor feedback release all switches". At this stage dr (b)(6) was using minimal to no pressure and was operating the system correctly. We followed protocol and released all switches and left the machine to rest and reset for 5 seconds. The machine reset by itself. The generator then reset and the led channel then turned yellow meaning activation of the handpiece. We the re-engaged to encounter the handpiece running by itself without pressing the button. Again the generator displayed the message "poor feedback release all switches" without dr (b)(6) actually activating the yellow button. I immediately told to him to cease all operations and suggested to change the cables, as i assumed there was an issue with the cable we were using. The cables were switched and the machine then reactivated. As soon as the new cable was connected the generator displayed the message "handset not detected". I again followed protocol stated in the surgical technique, which suggest an issue with handpiece. I explained to dr (b)(6), we should not continue with the oscar as it has encountered an issue. Dr (b)(6) then opted to finish removing the cup with curved manual osteotome's. The cup popped out after 2 taps and he was happy with this outcome. Following this i conducted my own testing on all handpieces and all cables in both channels. I come to the conclusion that the gold handpiece had failed. I unscrewed the end of the gold handpiece to discover the internal wiring had been compromised and was fried. The complaint report form also indicates: the device failure had no adverse effects on patient. The surgery was not completed with the device. A replacement device was not used to complete surgery: to complete surgery it was used manual osteotomes. The event did not lead to a clinically relevant increase in the duration of the surgical procedure. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative reports are not available. Copies of the x-ray images are not available. Patient current health condition: n/a. Manufacturer reference number: (b)(4). Distributor's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2018-00100 |
| MDR Report Key | 8127876 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2018-12-04 |
| 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 | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONECUTTER OSTEOTOME HANDSET |
| Generic Name | BONECUTTER OSTEOTOME HANDSET |
| Product Code | JDX |
| Date Received | 2018-12-04 |
| Returned To Mfg | 2018-11-21 |
| Model Number | OHB300/2 |
| Catalog Number | OHB300/2 |
| Lot Number | 3BH0158 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-04 |