MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/LT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hrs, hwc.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, a patient underwent revision surgery of a broken variable-angle (va) condylar plate on a two-year-old non-union fracture.Originally, the patient had implantation on (b)(6) 2017 for a femoral shaft fracture.During reoperation, the patient was revised with almost identical implants (minus the cortical screw in the middle) using a true bridge-plating technique.The plates and screws were successfully explanted.All screws were removed intact and the plate that was broken in two pieces was removed easily without additional difficulty.The surgery was successfully completed with no surgical delay.The surgeon believed that the cortical screw in the middle of the plate was the cause of the problem as it prevented the plate from acting as a bridging plate.Concomitant devices reported: va locking screw stardrive (part 02.231.260s, lot 9763966, quantity 1), va locking screw stardrive (part 02.231.260s, lot 9172456, quantity 1), va locking screw stardrive (part 02.231.270s, lot 9929463, quantity 1), va locking screw stardrive (part 02.231.270s, lot 9310584, quantity 1), locking screw (part 212.214s, lot l257591, quantity 4), locking screw (part 212.219s, lot 9898515, quantity 1) this report is for a va condylar plate.This is report 1 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.H3, h6: part: 02.124.415s , lot: 9709800 , manufacturing site: mezzovico , release to warehouse date: november 10, 2015 , expiry date: november 01, 2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The received broken va-lcp condylar plate was forwarded to the manufacturing site for evaluation.All relevant dimensions were as far as possible reinspected and no deviation from the specification could be detected.The review of the material certificate has shown that with 1.4441, the correct raw material was used and that the material was according to iso norm 5832-1 for surgical implants.The complaint is confirmed as the plate is broken as complained; this is also visible on the received x-rays.The exact cause of this breakage can afterwards not be defined.We can only assume that the in the complaint description mentioned 2-year-old non-union fracture did finally lead to a to a fatigue failure of the plate.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/LT-STER
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8772097
• MDR Text Key: 150427687
• Report Number: 8030965-2019-66089
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455931
• UDI-Public: (01)07611819455931
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415S
• Device Lot Number: 9709800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 07/26/2019
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L50 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L70 SST; VA LOCKSCR Ø5 SELF-TAP L70 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L50 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L70 SST; VA LOCKSCR Ø5 SELF-TAP L70 SST
• Patient Outcome(s): Required Intervention