MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP BUTTON HOOK PLATE/ 15MM/ LEFT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.914S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
Study no: no information provided: clinical adverse event received for pain/discomfort/prominence: device and procedure (relatedness).Device related: related.Procedure related: not related.Date of event: 04-04-2025.Date of implant: (b)(6) 2025.Date of revision: no information provided.Device location: left.Treatment/impact: no action taken.
Additional Manufacturer Narrative
Additional information has been received, the previously reported event is no longer considered reportable at this time as there was no failure of the device.No further follow-ups will be sent.

• Brand Name: 2.7MM TI VA LCP BUTTON HOOK PLATE/ 15MM/ LEFT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22214486
• Report Number: 8030965-2025-06001
• Device Sequence Number: 8148489
• Product Code: HRS
• UDI-Device Identifier: 07612334214843
• UDI-Public: (01)07612334214843
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.112.914S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: VA LOCKING.; UNK - SCREWS: VA LOCKING.
• Patient Sex: Unknown