MAUDE Adverse Event Report: SYNTHES GMBH LONG SCALPEL HANDLE

Catalog Number	03.010.491
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when utilizing the ans base instrument set and the tfna standard sets, numerous items broke/became faulty that caused roughly a 15 minutes of surgical delay.These items not working properly/breaking during the procedure and had to be removed from service.No fragments were left inside the patient, and the surgery was completed successfully.Additional 10-15 seconds fluoroscopy was required to assist with the procedure.There was no patient harm.Additional impacted products are captured under related complaint (b)(4).
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LONG SCALPEL HANDLE
• Common Device Name: SCALPEL HANDLE
• 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25567416
• Report Number: 8030965-2026-06394
• Device Sequence Number: 10250210
• Product Code: GDZ
• UDI-Device Identifier: 10886982069085
• UDI-Public: (01)10886982069085
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 03.010.491
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 06/22/2026; 07/16/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 06/29/2026; 07/17/2026
• 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: 4.2MM TROCAR 210MM; 4.2MM TROCAR 210MM; HANDLE F/SCALPEL LONG; HYBRID INSERTION HANDLE; RETENT PIN SCRDRIVER QC -HEX 12/ XL25; RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25; RETENTION PIN FOR SCRDRIVER SHORT / XL25; RETENTION PIN FOR SCREWDRIVER XL25; SILICONE HANDLE WITH QUICK COUPLING; T-HANDLE/CANNULATED WITH QUICK COUPLING; UNIV-CHUCK W/T-HANDLE; UNIV-CHUCK W/T-HANDLE
• Patient Sex: Unknown