MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.620S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent a surgery with the plate in question.The surgery was completed successfully with no surgical delay.After the surgery on (b)(6) 2025, the sales rep was informed that the plate dislocated.When the sales representative went to the hospital to confirm the x-ray, it was confirmed that the screw remained in the plate and the distal bony fragment, which was lumped with the shoulder joint, was displaced caudally by the weight of the arm.No screw fracture damage was seen.The revision surgery is scheduled on (b)(6) 2025, to remove the plate and replace with other company¿s implants.No further information is available.
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part# 04.112.620s, lot # 27937p0, manufacturing site: werk selzach logistik, manufacturing date: 16.July.2024, expiration date: (b)(6) 2034, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 21323482
• Report Number: 8030965-2025-01377
• Device Sequence Number: 8485417
• Product Code: HRS
• UDI-Device Identifier: 07612334214348
• UDI-Public: (01)07612334214348(17)340701(10)27937P0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: 04.112.620S
• Device Lot Number: 27937P0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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 Sex: Male