MAUDE Adverse Event Report: SYNTHES GMBH HAMMER GUIDE; HAMMER, SURGICAL

Catalog Number	03.010.170
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the t-handle and locking mechanism and interface to the finger reduction tool keeps sliding off.This was while performing the function before assembling the set before processing.The back slap pole that helps remove the nail (threads are worn); it will not screw into the back of the extraction bolt fully.It was noticed during routine inspection.The lid to the screw rack in volt php came apart on one side.Driving caps for tna nails had a set pin missing which does not keep the spring in place.There was no patient involvement.

• Brand Name: HAMMER GUIDE
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 25114742
• Report Number: 8030965-2026-04363
• Device Sequence Number: 10279798
• Product Code: FZY
• UDI-Device Identifier: 10886982068026
• UDI-Public: (01)10886982068026
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,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: 03.010.170
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/13/2026; 06/11/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMBINED HAMMER 500G; DRIVING CAP; HAMMER GUIDE; IM REDUCTION TOOL/CURVED QUICK COUPLING; T-HANDLE/CANNULATED WITH QUICK COUPLING; VOLT INSTR+IMPL TRAY F/PROX HUM 1 LEV H
• Patient Sex: Unknown