MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for SHARP HOOK 319.390 manufactured by Oberdorf Synthes Produktions Gmbh.
[107974608]
There was no known reported patient involvement associated with the complained event. Unknown when device malfunctioned. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 and is currently pending completion. 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
[107974609]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that upon return of loan kits it has been found during the inspection that the sharp hook l155 instrument? S tip has broken off and is missing. Unsure if this happened intraoperatively. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53655 |
| MDR Report Key | 7499890 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-04-18 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2014-09-30 |
| Date Added to Maude | 2018-05-09 |
| 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. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2018-05-09 |
| Returned To Mfg | 2018-05-14 |
| Catalog Number | 319.390 |
| Lot Number | 9143710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-09 |