MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; APPLIANCE,FIXATION,NAIL

Catalog Number 04.168.485S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer.Review/investigation.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.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) 2019, the patient underwent open reduction internal fixation surgery with fns.During the surgery, the surgeon inserted the 85 mm bolt into the bone after measuring with a depth gauge.In the final check, he found that the bolt protruded from the femoral head.The surgeon removed all devices and replaced them with a 75 mm bolt and 75 mm anti-rotation screw.The surgery was delayed by less than 30 minutes.No further information is available.Concomitant devices reported: unknown depth gauge (part #unknown, lot #unknown, quantity 1).Unknown plate (part #unknown, lot #unknown, quantity 1), unknown locking screw (part# unknown, lot #unknown, quantity 1).This complaint involves two (2) devices.This is 2 of 2 for report (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.Method codes: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was not returned.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.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: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9273568
• MDR Text Key: 184826590
• Report Number: 8030965-2019-69960
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089953
• UDI-Public: (01)07612334089953
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.485S
• Device Lot Number: 4L81106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Patient Sequence Number: 1
• Treatment: UNK - DEPTH GAUGES; UNK - PLATES; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention