MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-25 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Wrights Lane Synthes Usa Products Llc.
[143077293]
Occupation: reporter is a synthes employee. Part: 03. 111. 030; lot: l837377; manufacturing site: (b)(4); release to warehouse date: june 08, 2018. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. (b)(4). Visual inspection: the shaft for trephine attachments was received at us customer quality (cq) with all three of the distal prongs broken. The broken portions of the device were not returned to us cq. This is consistent with the reported complaint condition, thus confirming the complaint. Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed. Document/specification review: the following drawing was reviewed; connector trepane orthopedic foot. (b)(4). Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint. While no definitive root cause could be determined, it is possible that the device encountered unintended forces. No new malfunctions were observed during the course of this investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[143077294]
It was reported that on an unknown date, it was found out that a screwdriver shaft, drill sleeve, and trephine for a bone harvesting set was broken. It was observed at the sterile processing department (spd). Parts were immediately taken out of circulation, so the parts are no longer in the operating room. There was no patient involvement. This report is for a shaft for trephine attachments. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57628 |
| MDR Report Key | 8549413 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-25 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2018-06-08 |
| Date Added to Maude | 2019-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CO 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| 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 | 2019-04-25 |
| Returned To Mfg | 2019-04-05 |
| Model Number | 03.111.030 |
| Catalog Number | 03.111.030 |
| Lot Number | L837377 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |