MAUDE Adverse Event Report: Synthes Trauma : CrossRoads Extremity Systems, LLC Compression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thread Length 20mm; Orthopedic Manual Surgical Instrument

Catalog Number	03.900.349
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a compression wire from the the trileap universal fracture set broke while taking it out.The wire broke below the compression ball, where the threads start.The device was discarded.There was no reported patient or user harm.There was no significant delay.
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• Brand Name: Compression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thread Length 20mm
• Common Device Name: Orthopedic Manual Surgical Instrument
• Manufacturer (Section D): Synthes Trauma : CrossRoads Extremity Systems, LLC; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50855186
• Report Number: 3020584246-2026-00031
• Device Sequence Number: 13174674
• Product Code: LXH
• UDI-Device Identifier: 00810112596212
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial

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: 03.900.349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• 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