MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL XLG LT 11. 5X300MM; SCREW, FIXATION, BONE

Catalog Number	415101130L
Medical Device Problem Codes	Material Fragmentation (1261); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threads of the nail, which attach to the outrigger jig, stripped while backing out the nail.This resulted in a 30-minute surgical delay, though no adverse consequences were reported for the patient.To complete the procedure, a sterilized removal tool was used to extract the nail, and the implant was downsized to a 250 mm valor nail.The affected implant is available for manufacturer evaluation.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence were provided.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Correction to h6(method code).
Event or Problem Description
It was reported that the threads of the nail, which attach to the outrigger jig, stripped while backing out the nail.This resulted in a 30-minute surgical delay, though no adverse consequences were reported for the patient.To complete the procedure, a sterilized removal tool was used to extract the nail, and the implant was downsized to a 250mm valor nail.The affected implant is available for manufacturer evaluation.

• Brand Name: VALOR NAIL XLG LT 11. 5X300MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21708343
• Report Number: 3010667733-2025-00373
• Device Sequence Number: 4682717
• Product Code: HWC
• UDI-Device Identifier: 00840420125620
• UDI-Public: (01)00840420125620(11)230630(17)310630(10)1758689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 415101130L
• Device Lot Number: 1758689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Male