MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE ATTACHMENT FOR PEN DRIVE; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	05.001.037
Medical Device Problem Codes	Compatibility Problem (2960); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Device was used for treatment, not diagnosis.H11 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the k-wire attachment for pen drive device would break/damage the k-wire devices.It was further determined that the device cannot insert k-wire, locking mechanism stiff/stuck, and missing components - handle/lever.It was further determined that the device failed the following pretest steps: general condition, check the version of the sleeve for spring, check function of tensioning lever, and check clamping rang on tool coupling.It was noted in the service order that the device did not feed the k-wire device.This event did not occur during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2025.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Device was used for treatment, not diagnosis.H11 additional narrative: b5;h6.Investigation findings: corrected data: the device evaluation has been updated to remove previously reported failure of missing components - handle/lever and imdrf c07 - mechanical problem identified which was reported in error.A visual and functional assessment was performed on the device.The following steps failed: general condition.Check the version of the sleeve for spring.Check function of tensioning lever.Check clamping rang on tool coupling.During the service evaluation the following failures were identified: functional : device damages/breaks k-wire.Device interaction (2+ devices) : cannot insert k-wire.Functional : locking mechanism stiff/stuck.Conclusion: failure reported is confirmed.Root cause: component failure from wear.

• Brand Name: K-WIRE ATTACHMENT FOR PEN DRIVE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 23406149
• Report Number: 8030965-2025-10787
• Device Sequence Number: 17378595
• Product Code: HBE
• UDI-Device Identifier: 07611819167872
• UDI-Public: (01)07611819167872(10)3747409
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: 05.001.037
• Device Lot Number: 3747409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2011
• 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