MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL LG RT 11.5MMX250MM; SCREW, FIXATION, BONE

Catalog Number	415101125R
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the internal compression screw would not engage into the calc compression screw and would not back out of the nail.The internal compression screw cold welded inside the nail.The targeting guide was removed from the nail to remove the internal compression screw but were unable to either progress or remove the internal compression screw.Device was still able to achieve desired fusion.We were not able to utilize the internal compression of this product.The apposition of the ankle joint had obtained adequate fusion from the joint debridement.The surgeon preferred additional fusion with the internal compression which we were unable to utilize.The internal compression screw was left cold welded in the plantar/bottom aspect of the nail." it was additionally reported that there was a 35 minute surgical delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences 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.
Event or Problem Description
As reported: "the internal compression screw would not engage into the calc compression screw and would not back out of the nail.The internal compression screw cold welded inside the nail.The targeting guide was removed from the nail to remove the internal compression screw but were unable to either progress or remove the internal compression screw.Device was still able to achieve desired fusion.We were not able to utilize the internal compression of this product.The apposition of the ankle joint had obtained adequate fusion from the joint debridement.The surgeon preferred additional fusion with the internal compression which we were unable to utilize.The internal compression screw was left cold welded in the plantar/bottom aspect of the nail." it was additionally reported that there was a 35 minute surgical delay.

• Brand Name: VALOR NAIL LG RT 11.5MMX250MM
• 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20848801
• Report Number: 3010667733-2024-00949
• Device Sequence Number: 8100392
• Product Code: HWC
• UDI-Device Identifier: 00840420125613
• UDI-Public: (01)00840420125613(11)200422(17)280420(10)1675776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 415101125R
• Device Lot Number: 1675776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2020
• 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: 76 YR
• Patient Sex: Male