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 2020-03-27 for NAIL EXTRACTOR 03.037.032 manufactured by Wrights Lane Synthes Usa Products Llc.
[185546867]
Investigation summary: investigation flow: damage. Visual inspection: the nail extractor (p/n # 03. 037. 032, l/n # 9343591) was received at us cq with the distal threads stripped. This is consistent with the reported complaint condition, thus confirming the complaint. Dimensional inspection: dimensional analysis was completed. Conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information. This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation. No new, unique or different patient harms were identified because of this evaluation. 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 history lot. Part: 03. 037. 032. Lot: 9237381. Manufacturing site: (b)(6). Release to warehouse date: (b)(6), 2014. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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
[185546868]
It was reported that on an unknown date, during inspection at the sterile processing department (spd), a driving cap, radiolucent insertion handle, helical blade extractor and nail extractor were noted to have an unknown malfunction. The driving cap and the insertion handle where broke at the connection of the two and the helical blade extraction and the exaction nail were both stripped at the threads. There was no patient involvement. This complaint involves three devices. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01567 |
| MDR Report Key | 9889187 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2020-03-27 |
| 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 | SYNTHES HAEGENDORF GMBH-CN |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAIL EXTRACTOR |
| Generic Name | ROD,FIXATION,INTRAMEDULLARY |
| Product Code | HSB |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 03.037.032 |
| Catalog Number | 03.037.032 |
| Lot Number | 9237381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-27 |