MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE LATERAL/ CS3/ LEFT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.614S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Subject id: (b)(6).Study no: no information provided.Clinical adverse event received for (pain/discomfort/prominence) local discomfort due to plate that requires medical or surgical treatment device related: possible procedure related: no date of event: (b)(6) 2024, date of implant: (b)(6) 2024, date of revision: no information provided, device location: left.Treatment/impact: ibuprofen 600mg.
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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: e1.
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.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.H3, h6: 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.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 LATERAL/ CS3/ 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: 22062849
• Report Number: 8030965-2025-05082
• Device Sequence Number: 12672393
• Product Code: HRS
• UDI-Device Identifier: 07612334214300
• UDI-Public: (01)07612334214300
• 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: 2024
• 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,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: 04.112.614S
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/04/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/05/2025
• 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: CORTSCR ø2.7 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN
• Patient Sex: Male
• Patient Weight: 98 KG