MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR NAIL; SCREW, FIXATION, BONE

Model Number	415101120L
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition.
Event or Problem Description
It was reported that the patient underwent a surgery to remove the nail.Allegedly, the compression screw in the nail was defective which made it impossible to screw the extractor onto the nail to extract the nail correctly.The surgeon made two additional incisions at the tibia that were not planned to remove the nail.This resulted in the surgery lasting for 3 hours instead of 45 minutes.It also resulted in 3 months of convalescence instead of 2 weeks.

• Brand Name: VALOR NAIL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12763301
• Report Number: 0001043534-2021-00215
• Device Sequence Number: 14601341
• Product Code: HWC
• UDI-Device Identifier: 00840420125583
• UDI-Public: 00840420125583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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 Expiration Date: 11/27/2025
• Device Model Number: 415101120L
• Device Catalogue Number: 415101120L
• Device Lot Number: 1617100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• 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: Male