MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-11 for SHARP HOOK 319.39 manufactured by Synthes Tuttlingen.
[40202467]
Device was used for treatment, not diagnosis. Additional narrative: original implant date: (b)(6) 2016. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. Manufacturing date and location: august 2003, (b)(4). The dhr for this device is no longer available due to the age of the instrument (over twelve years old). Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[40202468]
It was reported that a patient went to surgery on (b)(6) 2016 for an open reduction internal fixation (orif) of the left elbow to repair an olecranon fracture. The surgeon noted during the review of the final x-rays that there was a metal fragment stuck in the fracture site of the patient. The surgeon had finished the plating but the patient was not yet sewn up. The surgeon was able to easily retrieve what was found to be the tip of a sharp hook that had unknowingly broken off during the surgery. Removing the fragment caused a ten minutes surgical delay without any additional medical intervention or harm to the patient. The surgery was successfully completed. The patient status outcome was stable at the end of surgery. It was reported by the reporter's conversation with the surgeon, confirming that the broken tip fo the sharp hook was indeed retrieved intra-operatively. To be specific, the surgeon stated that "it was sucked up by the suction tip. " this report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[42859440]
Co-morbidity added. Device was used for treatment, not diagnosis. 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
| Report Number | 9680938-2016-10033 |
| MDR Report Key | 5496311 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2016-03-11 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-03-11 |
| Catalog Number | 319.39 |
| Lot Number | MA35 |
| ID Number | (01)10886982190253(10)MA35 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |