MAUDE Adverse Event Report: Synthes Trauma : CrossRoads Extremity Systems, LLC TriLeap Lower Extremity Anatomic Plating System; Orthopedic Manual Surgical Instrument

Catalog Number	03.900.344
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an intra-operative procedure that comp wire f/ 3.0/3.5/4.0 pl thread 20mm was used.While two 20 mm olive wires were being used to compress a trileap plate, one wire bent between the cone and the ball of the olive wire and then broke below the cone, flush with the bone.The surgeon changed the surgical plan and used two crossing screws instead.There was no reported patient harm, but the procedure was prolonged by 5 to 10 minutes.The allegation was limited to the wire, and the broken wire remained in the patient.
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.

• Brand Name: TriLeap Lower Extremity Anatomic Plating System
• 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: angela marik ; 6423 shelby view dr.; suite 101; memphis, TN ; +1(901)221-8406
• MDR Report Key: 50858785
• Report Number: 3020584246-2026-00032
• Device Sequence Number: 9652126
• Product Code: LXH
• UDI-Device Identifier: 00810112596168
• 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: Other Health Care Professional
• 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: 03.900.344
• 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