MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TENDON SPACER SWANSON/HUNTER SIZING SET COLOR CODED 3-6MM; Template

Catalog Number	24370001
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "informed that the surgeon may have implanted a trial implant from swanson tendon rod consignment tray for a first stage reconstruction.Stryker rep not present at case.Notified of incident on (b)(6), 2026 at 4pm.Directed nurse to notify surgeon of findings.Hospital notified me the following morning (b)(6), 2026 that the surgeon had been made aware that evening.".

• Brand Name: TENDON SPACER SWANSON/HUNTER SIZING SET COLOR CODED 3-6MM
• Common Device Name: Template
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): Wright Medical Technology Inc; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25101723
• Report Number: 0008031020-2026-00619
• Device Sequence Number: 5079580
• Product Code: HWT
• UDI-Device Identifier: 00840420188373
• UDI-Public: 00840420188373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 24370001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/08/2026
• 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 Age: 56 YR
• Patient Sex: Male