MAUDE Adverse Event Report: Synthes GmbH; Screw, fixation, bone

Catalog Number	02.424.320
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date, that during a surgical procedure utilizing the volt distal radius plate, an issue was encountered with multiple locking screws failing to properly lock into the plate.Despite appropriate use of the designated guide block and following the recommended technique, the locking screws did not consistently engage and lock into the threaded holes of the plate as intended.Attempts were made to achieve proper screw engagement using the guide block; however, the screws continued to advance without achieving the expected locking mechanism.This resulted in difficulty obtaining secure screw-to-plate fixation and required removal of the plate.The product and associated instrumentation should be evaluated to determine whether there is a potential issue with the plate threads, locking screw threads, guide block alignment, or compatibility between the components.
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.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: Screw, fixation, bone
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Werk Grenchen (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50805244
• Report Number: 8030965-2026-09492
• Device Sequence Number: 20996040
• Product Code: HWC
• UDI-Device Identifier: 10886982316448
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 02.424.320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Age: 71 YR
• Patient Sex: Unknown