MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-25 for TREPHINE ATTACHMENT 12.5MM DIAMETER 387.662 manufactured by Oberdorf Synthes Produktions Gmbh.
[112193490]
Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). 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
[112193491]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown surgery performed on (b)(6) 2018, the trephine broke off and one of the tips created shards when doing do. X ray was used to determine nothing was left in the patient and surgeon was satisfied. The bone harvesting had been achieved so it was only the process of removing the shards that caused the delay. This report is for one (1) trephine attachment 12. 5mm diameter (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-54571 |
| MDR Report Key | 7634023 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-25 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2014-09-04 |
| Date Added to Maude | 2018-06-25 |
| 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 | 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 | 3 |
| Brand Name | TREPHINE ATTACHMENT 12.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-06-25 |
| Catalog Number | 387.662 |
| Lot Number | 9035629 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-25 |