MAUDE Adverse Event Report: Synthes GmbH VA-LCP; PLATE, FIXATION, BONE

Catalog Number	02.107.002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 6th july, 2026 that the 2.7 va locking screws had all begun backing out of the olecranon plate after initial surgery which was only a couple of weeks prior to removal.The skin around the plate had begun to break down so the hardware was removed.The patient experienced an adverse event and subsequently required revision surgery/hardware removal.The device was explanted due to skin breakdown/infection, and the patient required revision surgery.The patient experienced a clinical outcome, and is currently being staged for an upcoming revision procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11.Additional manufacturer narrative: a1: (b)(6).

• Brand Name: VA-LCP
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Synthes Elmira; 35 airport road; horseheads NY 14845
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50067412
• Report Number: 8030965-2026-07808
• Device Sequence Number: 10216681
• Product Code: HRS
• UDI-Device Identifier: 10886982029225
• UDI-Public: (01)10886982029225(10)76478P1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02.107.002
• Device Lot Number: 76478P1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/07/2026; Not provided; 09/07/2026; 09/15/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/10/2026; 08/20/2026; 09/08/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female