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 2015-12-02 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[32460583]
Report was initially submitted on (b)(6) 2015, but the fda site was down. Advised by fda on (b)(6) 2015 to resubmit medwatch. Device is an instrument and is not implanted or explanted. The 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 record review: manufacturing location: (b)(4)- manufacturing date: july 8, 2013. 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 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
[32460584]
Device report from synthes (b)(4) reports an event in the (b)(6) as follows: it was reported that the distal end of an instrument broke off during an unknown procedure on (b)(6) 2015. Per reports, the "normal technique" was adhered to during utilization. The surgery was not prolonged. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[41434230]
Device was used for treatment, not diagnosis. The subject device has been received and is currently in the evaluation process. 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
[44618124]
Product investigation summary: the evaluation has shown that one of the three prongs is broken off. The other prongs are bent inward. Due to these damages, it is not possible to check the relevant dimensions. In general, the device is in a used condition with visible stress marks on the hexagon and at the coupling piece. The manufacturing documents were reviewed with no complaint related issues found. The lot of nineteen (19) pieces was manufactured in july, 2013. The investigation review has shown that the correct material was used and that the hardness was (b)(4), which is within the specifications of (b)(4), per the drawing. The fracture face is homogenous, which indicates material conformity. Based on these findings, a manufacturing related issue can be excluded. The exact root cause cannot be definitively determined based upon the provided information alone. However, the returned condition with bent prongs is consistent with excessive off axis force to the distal tip. It is most probable that rough handling during surgery and/or not fully attaching the devices together has led to this complaint condition. No product related issues could be detected. 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
[44618125]
Clarification: it was further clarified that no broken pieces of the device were left in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2015-10522 |
| MDR Report Key | 5260137 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-02 |
| Date of Report | 2015-10-09 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2016-04-26 |
| Device Manufacturer Date | 2013-07-08 |
| Date Added to Maude | 2015-12-02 |
| 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 | 2015-12-02 |
| Returned To Mfg | 2016-03-14 |
| Catalog Number | 03.111.030 |
| Lot Number | 8376962 |
| ID Number | (01)07611819375901(10)8376962 |
| 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 | 2015-12-02 |