MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

Catalog Number 03.019.025

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent an open reduction internal fixation (orif) surgery for femoral medial neck fractures by using the femoral neck system (fns) implants.While drilling an anti-rotation screw with the drill bit after setting the stopper at 75 mm, the drilling went deeper than expected.It was confirmed that the stopper was set at 75 mm and it would not lock, the drill bit went back and forth between 75 mm and 80 mm.It was found that the the screwdriver is broken.The procedure was completed successfully.Patient outcome is reported as stable.Concomitant devices: unknown anti-rotation screw (part# unknown, lot# unknown, quantity# 1), unknown drill (part# unknown, lot# unknown, quantity# 1); drill bit ø4.3 l413 (part # 03.168.011, lot # f-23376, quantity 1).This report is for one (1) scrwdrvr f/4.5mm ti multiloc screws/slf-retain/330mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.This was found to be a duplicate.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.

• Brand Name: SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10379695
• MDR Text Key: 208007687
• Report Number: 8030965-2020-05741
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819427259
• UDI-Public: (01)07611819427259
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.025
• Device Lot Number: 9914477
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø4.3 L413; UNK - DRILL; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
• Patient Outcome(s): Required Intervention