MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR TARGETING GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	4150011000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Valor nail alignment gig is out of spec/has play and therefore causing surgical complications.
Event or Problem Description
Valor nail alignment gig is out of spec/has play and therefore causing surgical complications.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned device shows scratches and blemishes consistent with reusable instruments.Significant deformation could be seen at the base of the targeting guide.The cylindrical surface that interfaces with the guide connector exhibits extensive wear and abrasion.During functional testing, the locking lever/trigger mechanism exhibited slight looseness.When the guide connector was locked into position, the assembly exhibited a small degree of instability as slight movement could be observed.Based on investigation, the root cause was attributed to a wear related issue.The failure was caused by excessive use of the device over a prolonged period of time.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.The instructions for use were reviewed and states: surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling and end of functional life is normally determined by wear and damage due to use.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: VALOR TARGETING GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 23462714
• Report Number: 3010667733-2025-01274
• Device Sequence Number: 9084907
• Product Code: FZX
• UDI-Device Identifier: 00889797035545
• UDI-Public: (01)00889797035545(11)020512(10)1436313
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 4150011000
• Device Lot Number: 1436313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown