MAUDE Adverse Event Report: MONUMENT DEPUY SYNTHES PRODUCTS INC 2.7MM VA LCP CLAVICLE PLATE SHAFT/ XL/ RIGHT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	02.112.713S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a young patient had an osteotomy previously he then had an non-depuy synthes clavicle plate done, which broke, and patient then had a revision with a depuy synthes clavicle plate and this too ended up failing.The patient was then revised again and a dual plating was done.
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.
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: h3, h6: the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed the implant was observed broken in two fragments form the middle area.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the 2.7 va lcp clav pl shaft/ xl/ rt/ sile would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: manufacturing location: elmira / monument.Manufacturing date: 18-aug-2021.Expiration date: 01-aug-2031 part number: 02.112.713s, va-lcp clavicle plate 2.7, shaft, xl, right, ss, sterile.Lot number: 319p657 (sterile).Lot quantity: (b)(4).Review of the dhr file: part was manufactured by elmira; lot number: 302p031 qty (b)(4).Monument performs thermal rinse, sterilization and packaging operations.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd rev aa was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 319p657.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Device history review: a manufacturing record evaluation was performed for the finished device with batch number 319p657.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 2.7MM VA LCP CLAVICLE PLATE SHAFT/ XL/ RIGHT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): MONUMENT DEPUY SYNTHES PRODUCTS INC; 1101 synthes avenue; monument CO 80132
• 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: 22077417
• Report Number: 1719045-2025-00003
• Device Sequence Number: 9363099
• Product Code: HRS
• UDI-Device Identifier: 07612334214690
• UDI-Public: (01)07612334214690(17)310801(10)302P031
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 02.112.713S
• Device Lot Number: 302P031
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2021
• 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: Unknown