MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CLAVIC PL 2.7 SHAFT CS1 LE TAN; PLATE, FIXATION, BONE

Catalog Number	04.112.620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional 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.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 surgery was performed, and it was reported today that all four medial va 2.7 locking head screws fixed with the va clavicle plate have broken.Removal of the broken screws and revision surgery with a new plate is required.
Additional Manufacturer Narrative
Additional information has been received, the previously reported event under mrn 8030965-2025-00289 is no longer considered reportable at this time as there was no failure of the device.No further follow-ups will be sent under mrn 8030965-2025-00289.

• Brand Name: VA-LCP CLAVIC PL 2.7 SHAFT CS1 LE TAN
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21111979
• Report Number: 8030965-2025-00289
• Device Sequence Number: 7538952
• Product Code: HRS
• UDI-Device Identifier: 07612334215123
• UDI-Public: (01)07612334215123
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K203414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.112.620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/14/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown