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 UNK - DRILL BITS: TRAUMA manufactured by Wrights Lane Synthes Usa Products Llc.
[185539170]
Product complaint#: (b)(4). Complainant part received. This report is for an unknown - drill bits: trauma/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Reporter is a synthes rep. 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 unk - drill bits: trauma (3) devices. Investigation flow: damage. Visual inspection: unk drill bit (p/n unk) was received broken at the laser cut teeth segment on the shaft. The shaft was completely broken into 2 pieces and received at us cq. This damage is consistent with a device that was likely subjected to the unanticipated torsional forces during the tightening process, resulting in the shaft of the screwdriver twisting and breaking off. Based on the complaint description as well as dimensions and characteristics of the shaft, it is suspected that the device is 16mm cannulated flexible drill bit large quick coupling-266mm (03. 037. 002). No other issues were identified with the returned components of the device. Device failure/defect identified? Yes. Dimensional inspection: document/specification review: based on the date of manufacture the following. The device received was broken. Hence confirming the allegation. Conclusion: the complaint was confirmed for the unk drill bit (p/n unk) as the shaft of the device was completely broken. The unintended external forces might have contributed to the reported complaint condition. There was no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined. 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
[185539173]
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 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01574 |
| MDR Report Key | 9897876 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - DRILL BITS: TRAUMA |
| Generic Name | BIT DRILL |
| Product Code | HTW |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-12 |
| Catalog Number | UNK - DRILL BITS: TRAUMA |
| 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 |