MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-09 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[69575251]
There was no known reported patient involvement associated with the complained event. Unknown when device malfunctioned. Device is an instrument and is not implanted/explanted. A device history record (dhr) review request for part #: 03. 111. 030 / lot #: 8176415: manufacturing location: (b)(4), manufacturing date: 16-jan-2013. No non conformance reports (ncrs) 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. The device has been received and the product evaluation is in progress. No conclusion can be drawn. 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
[69575252]
It was reported that a synthes shaft for trephine attachments was discovered broken. It was clarified that two of the three prongs on the end of the device had broken off. The issue was identified after sterilization activities and no patient or procedure involvement was reported. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[73837604]
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device shaft for trephine attachments, part number 03. 111. 030, lot number 8176415). The subject device was returned with the complaint condition stating: this complaint is confirmed. Two of the three distal prongs have sheared off at their base. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. Visual inspection: two of the three distal prongs have sheared off at their base. Both prongs that broke off would each be approximately 11mm (calipers) in length with reference to drawing. Dimensional inspection of features relevant to this complaint such as prong width and prong thickness nearest location of breakage were not able to be taken at cq because the two prongs sheared off at their base and were not returned for evaluation. Drawing was reviewed during this investigation. No product design issues or discrepancies were observed. Most likely due to aggressive handling or aggressive sterile processing at spd (sterile processing dept). 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 | 9612488-2017-10103 |
| MDR Report Key | 6391074 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-16 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2013-01-16 |
| Date Added to Maude | 2017-03-09 |
| 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 | MICHAEL COTE |
| 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 | 2017-03-09 |
| Returned To Mfg | 2017-03-06 |
| Catalog Number | 03.111.030 |
| Lot Number | 8176415 |
| 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 | 2017-03-09 |