MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-07-14 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[22384326]
Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[22384327]
It was reported that the shaft for trephine attachments was broken. One of the prongs is broken. There was not a patient involved; it was found during cleaning. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[25264766]
Additional narrative: a product investigation was performed? One shaft for trephine attachment (part number 03. 111. 030, lot number 2550855) was received. The complaint condition is confirmed as one of the three prongs was received broken off of the main body of the device. The returned condition is consistent with excessive off axis force to the distal tip. The root cause cannot be definitively determined. It is most probable that rough handling during surgery or sterile processing and/or not fully attaching the devices together has led to this complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. Further evaluation at the chu shows that this device is part of the bone harvesting set for bone harvesting (e. G. , form the calcaneus, proximal tibia or iliac crest) and bone biopsies. Various sized trephine and extraction attachments connect to the shaft which connects to the handle during use. This information is provided per the orthopaedic foot instruments technique guide. The returned device was received with one of the three distal prongs broken off. The break is transverse and located at the base of the prong. No inconsistences were noted on the fracture surface. The broken piece is approximately 12. 4mm long. The balance of device shows moderate wear and is in working condition. Thus, the complaint condition is confirmed and consistent with the reported condition but cannot be replicated as the device is already broken. The returned condition is consistent with excessive off axis force to the distal tip. It is most probable that rough handling during surgery or sterile processing and/or not fully attaching the devices together has led to this complaint condition. However, as the condition was reported to have been discovered in sterile processing the specific circumstances at the time of the damage are unknown and the root cause cannot be definitively determined. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. 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 | 9612488-2015-10370 |
| MDR Report Key | 4912459 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-07-14 |
| Date of Report | 2015-07-03 |
| Date of Event | 2015-07-03 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2015-08-06 |
| 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 | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2015-07-14 |
| Returned To Mfg | 2015-08-12 |
| Catalog Number | 03.111.030 |
| Lot Number | 2550855 |
| 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 | 2015-07-14 |