MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-11 for SHARP HOOK 319.390 manufactured by Synthes Bettlach.
[33942515]
Device was used for treatment, not diagnosis. Unknown if patient was involved or when device malfunctioned. Device is an instrument and is not implanted/explanted. (b)(6). (b)(4). Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records was conducted. The report indicates that the 319. 390 / 2101796 manufacturing site: (b)(4), manufacturing date: 07. Jul. 2004, expiry date: - no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[33942516]
Report from synthes europe reports an event in (b)(6) as follows: it was reported that an instrument was broken, half the hook is snapped off. This report is 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[35747015]
A product investigation was completed: the part is broken as described in the complaint description. Our investigation shows that the article is over all in a good condition, nevertheless that the hook is broken off. Measurements on the broken position are not possible about the breakage. A device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure. There is no specific information about what happened to this article with the customer; based on this we are not able to determine the exact reason for this problem, but it is likely that wear and tear from use over the years (as the instrument is over 11 years old) and/or high applied mechanical force, led to this damage. No product problem identified; no product fault could be detected. 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 | 9612488-2015-10627 |
| MDR Report Key | 5290303 |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-23 |
| Date Mfgr Received | 2015-12-24 |
| Device Manufacturer Date | 2004-07-07 |
| Date Added to Maude | 2015-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| 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 | 2015-12-11 |
| Returned To Mfg | 2015-12-08 |
| Catalog Number | 319.390 |
| Lot Number | 2101796 |
| ID Number | (01)07611819020948(10)2101796 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-11 |