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

Catalog Number	02.424.318
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vdr plate and volt lock scr were involved in an intra-operative event during a volt distal radius procedure.The distal-most ulnar hole of the plate would not allow a locking screw to lock into the plate.Proper instrumentation was used, the hole was drilled at the nominal angle through the guide block with the locking drop-in guide, and the guide was heard clicking into place.When the screw threads contacted the plate, some resistance was encountered, after which the screw began spinning in the plate without resistance.No patient or user harm was reported; however, the procedure was prolonged by 10 minutes.The plate remained implanted and was not available for return, and the screw was discarded and was also unavailable for return.
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.H11.Additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• Brand Name: VOLT
• 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: 50931851
• Report Number: 8030965-2026-09886
• Device Sequence Number: 9589118
• Product Code: HWC
• UDI-Device Identifier: 10886982316400
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K233665
• 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

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: 02.424.318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• 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 Sex: Unknown