MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM 03.010.473 manufactured by Wrights Lane Synthes Usa Products Llc.
[185915983]
(b)(6). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[185915984]
It was reported that on (b)(6) 2020, the patient underwent removal of the broken greater trochanter femoral recon nail (frn). While the surgeon was impacting the new greater trochanter frn into the patient, the driving cap snapped and broke off inside the insertion handle. The surgeon had to get new equipment in the room to finish the case. It was also reported that the screwdriver broke during the case. Surgery was completed successfully. This report captures the intraoperative event of driving cap and screwdriver breakage while related complaint (b)(4) captures the postoperative event of femoral recon nail (frn) breakage. Concomitant devices reported: radiolucent insertion handle frn (part 03. 033. 001, lot 10l750732, quantity 1) and 9 mm / ti cann frn / gt 420mm / left - sterile (part 04. 033. 973s, lot 2l80025, quantity 1). This report involves one (1) inter-lock screwdriver t25/3. 5mm hex/224mm. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01529 |
| MDR Report Key | 9884156 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| 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 | WERK H |
| 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 | INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 03.010.473 |
| Catalog Number | 03.010.473 |
| Lot Number | 1L54567 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |