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

Catalog Number 02.124.414S

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional procode: hrs, hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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) 2021 during an unknown procedure, the va-lcp condylar plate broke.The plate was fixed with (10) screws.There is no further information available.Concomitant devices reported: unknown screws (part# unknown; lot# unknown; quantity: 10).This report is for (1) 4.5mm va-lcp curved condylar plate/14hole/301mm/rt-ster.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Visual inspection: the va-lcp condylar plate 4.5/5.0 r 14ho l30 (p/n: 02.124.414s, lot #: 70p8596) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken at the sixth hole.No other issues were observed with the returned device.The device failure/defect is identified.Dimensional inspection: the measured dimensions were found to be within the given specifications per the drawings referenced above.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint is confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the va-lcp condylar plate (p/n: 02.124.414s, lot #: 70p8596).There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the provided information we are not able to determine the exact cause.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot product code 02.124.414s, lot number 70p8596, manufacturing site: mezzovico, release to warehouse date: oct 19, 2020, expiry date: oct 01, 2030.A manufacturing record evaluation was performed for the sterile finished device lot number, and no non-conformances were identified.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/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11734544
• MDR Text Key: 261211871
• Report Number: 8030965-2021-03339
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455924
• UDI-Public: (01)07611819455924
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414S
• Device Lot Number: 70P8596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 06/10/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA