MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for DRIVING CAP/THREADED 03.010.523 manufactured by Wrights Lane Synthes Usa Products Llc.
[185538032]
Product complaint#: (b)(4). Device returned. A review of the device history record. Device history lot. Part number: 03. 010. 523. Lot number: 8279162. Manufacturing site:(b)(6). Release to warehouse date: (b)(6) 2013. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. All parts were reworked and inspected to 100% according the manufacturing documents. Device history batch - null. Investigation summary background: it was reported that on (b)(6), 2020, it was noticed that the inter-lock screwdriver, driving cap threaded and radiolucent insertion handle femoral recon nail were damaged and were no longer be usable. There was no patient involvement. This complaint involves three devices. Investigation flow: damage. Visual inspection: the driving cap/threaded (part # 03. 010. 523) was received at us cq. The threaded distal tip broken off at the most proximal thread form. The device had surface scratches along the shaft and several dents on the top of the proximal head from hammer blows. These cosmetic issues are consistent with normal wear. No other issues were identified with the device. The received condition is consistent with the complaint condition thus the complaint is confirmed. Device failure/defect identified? Yes. Dimensional inspection: due to the break being slightly oblique in nature and it only leaving the most proximal thread, it was not possible to obtain an accurate measurement of the minor/major diameter of the threaded tip. The diameter of the grove just proximal to the broken tip as well as the shaft diameter was measured instead. Drawings were reviewed: conclusion: the measuring result does show conformity. Document/specification review: the following drawing, reflecting the manufactured and current revision, was reviewed. - connector for insertion handle se_380067 rev l. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. Conclusion: the complaint condition is confirmed for the driving cap/threaded (part # 03. 010. 523) as the threaded distal tip was broken off at the most proximal thread form. While no definitive root cause could be determined, it is possible the device encountered unintended forces during use (off-axis or excessive hammer blows based on the numerous dents on the proximal surface). There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings relevant actions have been taken to address the issue. The need for further corrective/preventive action will be assessed, additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. 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
[185538033]
It was reported that on (b)(6), 2020, it was noticed that the inter-lock screwdriver, driving cap threaded and radiolucent insertion handle femoral recon nail were damaged and were no longer be usable. There was no patient involvement. This complaint involves three devices. This report is 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01590 |
| MDR Report Key | 9897882 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVING CAP/THREADED |
| Generic Name | MISC, ORTHO, SURGICAL, INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-28 |
| Model Number | 03.010.523 |
| Catalog Number | 03.010.523 |
| Lot Number | L504146 |
| 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 | 2020-03-30 |