MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-22 for TREPHINE ATTACHMENT 12.5MM DIAMETER 387.662 manufactured by Synthes Bettlach.
[21557240]
Device report from synthes europe reports an event in the (b)(6) as follows: it was reported that the trephine broke into two (2) pieces while the surgeon was attempting to obtain a bone dowel during a surgical procedure. The surgeon was using the bone graft harvesting set. All pieces of the broken device were retrieved and the procedure was completed successfully with another size trephine. A fifteen (15) minute delay was noted. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21707693]
Device is an instrument and is not implanted or explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). The investigation could not be completed; no conclusion could be drawn as no product was received. Device history review: manufacturing location: (b)(4) - manufacturing date: january 24, 2014. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device 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 | 9612488-2015-10344 |
| MDR Report Key | 4859311 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-06-09 |
| Device Manufacturer Date | 2014-01-24 |
| Date Added to Maude | 2015-07-17 |
| 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 | 0 |
| Event Location | 0 |
| 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 | TREPHINE ATTACHMENT 12.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2015-06-22 |
| Catalog Number | 387.662 |
| Lot Number | 8749539 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-22 |