MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CABLE/WIRE INSTRUMENTS; WIRE, SURGICAL

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - cable/wire instruments/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for subtrochanteric femoral fracture with expert afn.The surgeon initially chose to use reconstruction locking.During the surgery, the guide wire for hip screw was interfered with the nail.The surgeon was adjusted the instruments and drilled for hip screw.However, during hip screw insertion, the screw interfered with nail.He completed the surgery by standard locking instead of reconstruction locking.There was no interference in procedures of standard locking.The surgery was delayed by 90 minutes.The procedure was completed successfully.The patient outcome was stable.This is report 03 of 03 of (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.H6: code 3191 used to capture modified surgical procedure.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: UNK - CABLE/WIRE INSTRUMENTS
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9706497
• MDR Text Key: 191322040
• Report Number: 8030965-2020-01105
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention