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 2019-04-01 for HANDLE FOR 90? SCREWDRIVER 03.505.004 manufactured by Wrights Lane Synthes Usa Products Llc.
[140613124]
Additional procodes: dzj, hxx. Part: 03. 505. 004; lot: 8062713; manufacturing site: (b)(4), supplier: (b)(4); release to warehouse date: november 27, 2006 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: visual inspections revealed that the distal alignment tab and distal tip threads were found stripped / worn. The reported condition for bent is not confirmed. The mating part was not returned to replicate the reported condition of loose/ would not hold. Hence, we cannot confirm the loose complaint. Functional test: it was not performed as the mating part was not returned for the investigation. Document/ specification review: the following document was reviewed. Handle for 90? Screwdriver dimensional inspection: dimensional inspection was not performed due to manufacturing damages / stripped threads. Device history record (dhr) review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified. Conclusion: the reported conditions are not confirmed. Regarding distal alignment tab and distal tip threads, - a definitive root cause could not be determined. It is possible that rough handling during use and/or processing could have contributed to the stripping of the threads and tab. During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[140613125]
It was reported that after thoracic surgery on (b)(6) 2019, when reassembling the 90-degree drill, the sales consultant noticed that the nut holding the handpiece was stripped and would not hold together. There was no patient consequence. This report is for a handle for 90? Screwdriver. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57206 |
| MDR Report Key | 8470749 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-01 |
| Date of Report | 2019-02-10 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2006-11-27 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| 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 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDLE FOR 90? SCREWDRIVER |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-04-01 |
| Returned To Mfg | 2019-02-25 |
| Model Number | 03.505.004 |
| Catalog Number | 03.505.004 |
| Lot Number | 8062713 |
| 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 | 2019-04-01 |