MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/8HOLE/195MM/RT-STER; PLATE, FIXATION, BONE

Catalog Number	02.124.408S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the va-lcp condylar plate 4.5/5.0 r 8ho l195 was broken from the one of the holes near to the head chamfer detail.The broken surface suggest that the fracture was caused in one single stress event.No material issues were identified.Therefore, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined based on the evidence provided.In addition, the device shows signs of explantation damage on the upper surface.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the va-lcp condylar plate 4.5/5.0 r 8ho l195 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part number: 02.124.408s lot number: 3906p59 manufacturing site: mezzovico release to warehouse date: 07 feb 2023 expiration date: 01 feb 2033 a manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The device was received for analysis.There was no product malfunction or patient harm reported with the returned device.Upon inspection, it was noted to be broken.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8HOLE/195MM/RT-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21101803
• Report Number: 8030965-2025-00239
• Device Sequence Number: 8935321
• Product Code: HRS
• UDI-Device Identifier: 10886982042781
• UDI-Public: (01)10886982042781(10)3906P59
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.124.408S
• Device Lot Number: 3906P59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 SELF-TAP L44 SST; LOCKSCR Ø5 SELF-TAP L44 SST; VA LOCKSCR Ø5 SELF-TAP L32 SST; VA LOCKSCR Ø5 SELF-TAP L36 SST; VA LOCKSCR Ø5 SELF-TAP L40 SST; VA LOCKSCR Ø5 SELF-TAP L46 SST; VA LOCKSCR Ø5 SELF-TAP L46 SST; VA LOCKSCR Ø5 SELF-TAP L80 SST; VA LOCKSCR Ø5 SELF-TAP L80 SST; VA LOCKSCR Ø5 SELF-TAP L80 SST; VA LOCKSCR Ø5 SELF-TAP L85 SST; VET LOCKSCR Ø5 SELF-TAP L75 SST
• Patient Sex: Unknown