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 2017-11-15 for TREPHINE ATTACHMENT 9.5MM DIAMETER 387.660 manufactured by Synthes Bettlach.
[93295269]
Patient? S weight is unknown. (b)(4). Lot number unknown. 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. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[93295270]
It was reported that during an unknown fixation surgery on (b)(6) 2017 a 9. 5 mm diameter trephine attachment got caught in a wire as the surgeon was removing it from the patient's foot and broke. The procedure was already finished when the device broke. No fragments were generated in the patient; but, pictures of the device received show the tip of the device broke. There was no reported surgical delay or patient harm. The patient was reported to be in great condition following the procedure. Concomitant devices reported: wire (part # unknown, lot # unknown, quantity 1). This report is for one (1) trephine attachment 9. 5mm diameter. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10583 |
| MDR Report Key | 7033988 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-15 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2013-12-09 |
| Date Added to Maude | 2017-11-15 |
| 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 | 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 | TREPHINE ATTACHMENT 9.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2017-11-15 |
| Catalog Number | 387.660 |
| Lot Number | 8669635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-11-15 |