MAUDE Adverse Event Report: Wright Medical Technology Inc PROPHECY C-BRACKET INBONE TOTAL ANKLE; Orthopedic manual surgical instrument

Catalog Number	PTA00010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an inbone case, the c-bracket (b)(6) was not functioning properly, as the side knob seems to be cross threaded and won't tighten or loosen.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: PROPHECY C-BRACKET INBONE TOTAL ANKLE
• Common Device Name: Orthopedic manual surgical instrument
• Manufacturer (Section D): Wright Medical Technology Inc; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): Wright Medical Technology, Inc.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50841195
• Report Number: 3010667733-2026-01261
• Device Sequence Number: 10338872
• Product Code: LXH
• UDI-Device Identifier: 00889797051934
• UDI-Public: 00889797051934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: PTA00010
• Device Lot Number: 2906896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown