MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC HUNTER TENDON ROD 4MM X 24.5CM; SPATULA, ORTHOPEDIC

Catalog Number	TR400000
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the standard hunter tendon rod failed in patient.The physician explained that the suture tied into implant broke/implants core seemed hollowed out.Replaced with same rod.
Event or Problem Description
It was reported that the standard hunter tendon rod failed in patient.The physician explained that the suture tied into implant broke/implants core seemed hollowed out.Replaced with same rod.
Additional Manufacturer Narrative
The reported event could not be confirmed, as the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible because the product was not returned for investigation.A review of the device history for the reported lot did not identify any abnormalities.No corrective actions are required at this time.A review of the labeling did not identify any abnormalities.No indications of material-related, manufacturing-related, or design-related issues were identified during the investigation.More detailed information regarding the complaint event, including preoperative and postoperative radiographs as well as the affected device, is required in order to determine the root cause of the complaint event.If the device is returned or if additional information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the standard hunter tendon rod failed in patient.The physician explained that the suture tied into implant broke/implants core seemed hollowed out.Replaced with same rod.
Additional Manufacturer Narrative
Correction - d9, h6 (device code, method code, results code) the reported event could be confirmed since the device was returned for evaluation and matches the alleged event the device inspection reveals that the visual inspection of the device received confirms the reported breakage.The device is fractured from the ends and slight deformation can also be observed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation the available information was reviewed by lcm expert and opined that regarding tr400000, the polyester core is present (as i cut the implant in several spots and was able to see the core).Additionally, i compared the polyester core cross-section of the surgeon provided tr400000 and pt400000 with each other; the comparison indicates the size, thickness, etc of the polyester cores are equivalent.The suture appears to have been placed prior to where the polyester core started in the device (~4 mm from device end).I was able to see the deformation of the silicone elastomer near the suture site.The rmf indicates failure can occur when deformation in the silicone elastomer is noted.I do not see anything in the rmf that shows failure due to suture placement.Only failure due to mechanical stress typically due to patient overusage during healing period or poor surgeon choice of size of implant to withstand patient range of motion.From everything i can tell, the devices were manufactured according to specification.It appears that the device was unable to withstand the stress during patient forces during the healing period, for whatever reason.More detailed information about the complaint event, pre and post operative radiographs must be available in order to determine the root cause of the complaint event.If any further information is provided the investigation report will be reassessed.

• Brand Name: HUNTER TENDON ROD 4MM X 24.5CM
• Common Device Name: SPATULA, ORTHOPEDIC
• 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 ; 2018315000
• MDR Report Key: 23821729
• Report Number: 3010667733-2025-01524
• Device Sequence Number: 9974525
• Product Code: HXR
• UDI-Device Identifier: 00840420128959
• UDI-Public: (01)00840420128959(11)241017(17)321017(10)1801733
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K853436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TR400000
• Device Lot Number: 1801733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/13/2026; 06/18/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/24/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown