MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for STARDRIVE SCREWDRIVER SHAFT T8 105MM 314.467 manufactured by Wrights Lane Synthes Usa Products Llc.
[185119629]
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. Additional product code: kwq. Reporter is company representative. Investigation summary: investigation flow: damage. Visual inspection: the screwdriver shaft t8 self-hold (p/n: 314. 467, lot number: h442153) was received at us cq. Upon visual inspection, the driving threads are stripped. Device failure/defect identified? Yes. Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage. Document/specification review: no design issues or discrepancies were identified. Complaint confirmed? Yes. Investigation conclusion: this complaint is confirmed as the driving threads are stripped. No definitive root cause could be determined based on the provided information. No new, unique or different patient harms were identified as a result of this evaluation. 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, 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 history lot: part#: 314. 467, synthes lot#: h442153, supplier lot#: na, release to warehouse date: feb 09, 2018, manufactured by synthes monument no ncr's were generated during production. Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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
[185119630]
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the screwdriver wouldn't to catch the screw head. There was no surgical delay reported. There was no patient consequence. Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity# 1). This complaint involves one device. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01549 |
| MDR Report Key | 9884391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2020-03-26 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STARDRIVE SCREWDRIVER SHAFT T8 105MM |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 314.467 |
| Catalog Number | 314.467 |
| Lot Number | H442153 |
| 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 | 2020-03-26 |