MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/RT-STER; PLATE, FIXATION, BONE

Catalog Number	04.115.850S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).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: 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) 2024, the patient underwent an unknown surgery for radius with the plate and the screws.As the bone adhesion resulted, the removal surgery was performed on (b)(6) 2025.At that time, it was discovered that the most distal most ulnar screw had broken at the neck.The broken screw shaft was slightly protruding, so it was filed down with a halo reamer and removed with an extraction bolt.The surgeon confirmed that there was no residue based on the fluoroscopy and postoperative x-rays.The surgery was completed successfully within 30mins of delay.On (b)(6) 2025, the sales rep looked at the x-rays and ct scans with the surgeon, but it is unclear when the screw broke.No further information is available.Note: two screw part numbers are listed, but it is unclear which one broke.Looking at the history at the time, only the above two-part numbers were used.
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.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.Device history review: part number: 04.115.850s, lot number: 14014p9, manufacturing site: mezzovico, release to warehouse date: 30 apr 2024, expiration date: 01 apr 2034, a manufacturing record evaluation was performed for the sterile finished lot number, 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: 2.4MM TI VA-LCP VOLAR RIM DSTL RAD PL/7H HD/5H SHFT/RT-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); 1101 synthes avenue; mezzovico 275-0 016; SZ 275-0016
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22351177
• Report Number: 8030965-2025-06583
• Device Sequence Number: 20068892
• Product Code: HRS
• UDI-Device Identifier: 10886982105172
• UDI-Public: (01)10886982105172(17)340401(10)14014P9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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: 04.115.850S
• Device Lot Number: 14014P9
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown