MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER HANDLE/LARGE/AO QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.430.002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the "03.430.002 screwdriver handle/large/ao qc" has broken screw from the provided photos.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The broken screw could affect the functionality of the depth gauge.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the screwdriver handle/large/ao qc would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to caused traced to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history part # 03.430.002 synthes lot # br696616 supplier lot # br696616 release to warehouse date: 27 nov 2024 expiration date; na supplier: (b)(4).No ncr's generated during production.
Event or Problem Description
It was reported the quick connect of handle is no longer attached to the handle.No patient harm.No surgical delay.

• Brand Name: SCREWDRIVER HANDLE/LARGE/AO QC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25637256
• Report Number: 8030965-2026-06646
• Device Sequence Number: 21291330
• Product Code: LXH
• UDI-Device Identifier: 10886982340801
• UDI-Public: (01)10886982340801(10)BR696616
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: 03.430.002
• Device Lot Number: BR696616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sex: Unknown