MAUDE Adverse Event Report: SYNTHES GMBH UNK - GUIDE/COMPRESSION/K-WIRES; WIRE, SURGICAL

Catalog Number	UNK - GUIDE/COMPRESSION/K-WIRE
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
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.
Event or Problem Description
It was reported that tfna fem nail ø12 le 125° l235 timo15 and guide sleeve yell were involved in an intra-operative event.During a tfna case, after use of the lateral cortex opening drill bit and tapered stepped reamer, metal shavings were observed in the proximal femur and around the drill bit, and the guidewire was noted to be slightly bent.The surgeon elected to leave the metal shavings and nail in situ and requested the drill bit and guide sleeve be sent for testing to determine the source of the shavings.There was no reported patient consequence or clinical symptoms.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d10.H3, h6: photo investigation the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the tfna fem nail ø12 le 125° l235 timo15 shows signs of fracture, however with the evidence provided is not possible to determine the breakage or deforming of the guide sleeve yell.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the guide sleeve yell would have not contributed to the complained issue.Based on the investigation findings, 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 reported 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 lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 24875275
• Report Number: 8030965-2026-03449
• Device Sequence Number: 9878136
• Product Code: LRN
• UDI-Device Identifier: 10886982070333
• UDI-Public: (01)10886982070333(10)L166732
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: UNK - GUIDE/COMPRESSION/K-WIRE
• Device Lot Number: L166732
• 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: 03/28/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/29/2026; 05/12/2026; 05/14/2026; 06/22/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/01/2026; 05/12/2026; 05/15/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2016
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT F/LATERAL CORTEX OPENING F/QUI.; FIX-SLEEVE F/STEPPED REAM.
• Patient Age: 80 YR
• Patient Sex: Unknown