MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-15 for TREPHINE ATTACHMENT 10.5MM DIAMETER 387.661 manufactured by Synthes Bettlach.
[36076998]
Device is an instrument and is not implanted/explanted. Manufacturing location: (b)(4). Manufacturing date: february 25, 2011. The review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[36076999]
It was reported that upon inspection it was noted that the trephine attachment was broken at the end of the instrument. The tip was described as scalloped with one prong broken off and missing. There was no patient involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[38871740]
A product investigation was completed: one (1) 10. 5mm trephine attachment (part 387. 661, lot 2677663, manufactured february 2011) was returned with a complaint stating that the tip was scalloped with one prong broken off and missing. Upon evaluation of the returned instrument, one of the teeth was completely broken off. The complaint is confirmed. The 10. 5mm trephine attachment (part 387. 661) is part of the orthopedic foot instruments set and is included in the bone harvesting module case. When used in conjunction with the silicone handle (03. 111. 013) and the shaft for trephine attachment (03. 111. 030), the trephine attachments are intended to cut through the bone and extract bone graft. Alternatively, extraction attachments can be used to if a bone graft cannot be removed with the trephine attachments. The relevant product drawings were reviewed during the investigation. The returned trephine attachment was found suitable to determine the intended device design, application, and dimensional conformity. It is likely that repeated use and excessive force over the last five (5) years contributed to the complaint condition. No design issues were noted and so no corrective action is warranted at this time. 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 | 9612488-2016-10029 |
| MDR Report Key | 5370071 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-15 |
| Date of Report | 2015-12-31 |
| Date Mfgr Received | 2016-02-16 |
| Device Manufacturer Date | 2011-02-25 |
| Date Added to Maude | 2016-01-15 |
| 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 | 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 10.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2016-01-15 |
| Returned To Mfg | 2016-01-07 |
| Catalog Number | 387.661 |
| Lot Number | 2677663 |
| ID Number | (01)10886982197719(10)2677663 |
| 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 | 2016-01-15 |