MAUDE Adverse Event Report: Synthes GmbH 3.2MM WIRE GUIDE SLEEVE; Orthopedic Manual Surgical Instrument

Catalog Number	03.037.018
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
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.H11.Additional manufacturer 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 stepped ream for tfna helical blade and screw was used during insertion of a tfna nail.During preparation for the proximal locking portion of the case, the 10 mm cannulated drill bit was used without incident, after which the 6/9 tapered drill bit fractured at the tip in the femoral neck and was described as crumbling like dust after brief contact in the patient.It was also reported that substantial torque was applied to the insertion handle and aiming arm jig to achieve trajectory and reduction, and that the 3.2 guide wire bent during insertion of the lag screw head element.Additional impacted products were the insert handle, 3.2 mm wire guide sleeve, lock insert for aim arm, 3.2 mm trocar, blade/screw guide sleeve, and 125 degree aiming arm.Fragments were generated, retained in the patient, and additional intervention was required to remove the retained fragments.

• Brand Name: 3.2MM WIRE GUIDE SLEEVE
• Common Device Name: Orthopedic Manual Surgical Instrument
• 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 ; +1(908)386-3534
• MDR Report Key: 50936956
• Report Number: 8030965-2026-09923
• Device Sequence Number: 21213848
• Product Code: LXH
• UDI-Device Identifier: 10886982070340
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 03.037.018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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
• Patient Sex: Unknown