MAUDE Adverse Event Report: SYNTHES GMBH VOLT; SCREW, FIXATION, BONE

Catalog Number	02.424.310
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2.4mm volt(tm) locking screw 18mm t8, 2.4mm volt(tm) locking screw 19mm t8, volt lock scr ø2.4 t8 l10 sst, volt lock scr ø2 t6 l17 sst, volt lock scr ø2 t6 l15 sst, 2.4 volt(tm) condylar pl 2h hd/6h/54mm, and 2.0 volt(tm) comp strght pl 10h/52mm were involved in an event during an open reduction and internal fixation of the distal radius and ulna.During fixation of the ulna, one hole in each of the 2.4 volt condylar plate 6h and 2.0 compact volt straight plate had difficulty accepting locking screws.Multiple locking screws of different lengths were tried, and the holes were redrilled at the nominal angle.After several attempts, the holes eventually accepted the locking screws.There was no reported patient or user harm, and no significant delay occurred.
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 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 ; 9083863534
• MDR Report Key: 25069448
• Report Number: 8030965-2026-04190
• Device Sequence Number: 18815308
• Product Code: HWC
• UDI-Device Identifier: 10886982316240
• UDI-Public: (01)10886982316240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K233665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.424.310
• 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: 04/19/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/04/2026
• 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