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

Catalog Number	4150011000
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: visual examination of the returned device shows scratches and blemishes consistent with reusable instruments.Dents and deformation can be at the base of the targeting guide.Upon functional testing with a valor nail, the targeting guide was found to align properly with the nail and functions as intended.A drill bit was successfully passed through both proximal holes of the targeting guide and the valor nail with no issues noted.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that during a medical procedure code 44180025 did not guarantee the screws tightening as it went off when it was tensioned and code 4150011000 did not allow the centering of the 2 proximal holes.The procedure was completed successfully by free-hand-technique with forcing the screwdriver.
Event or Problem Description
It was reported that during a medical procedure code 44180025 did not guarantee the screws tightening as it went off when it was tensioned and code 4150011000 did not allow the centering of the 2 proximal holes.The procedure was completed successfully by free-hand-technique with forcing the screwdriver.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20771096
• Report Number: 3010667733-2024-00901
• Device Sequence Number: 8182052
• Product Code: FZX
• UDI-Device Identifier: 00889797035545
• UDI-Public: (01)00889797035545(11)190909(10)2025141
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/07/2025

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: 2025141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• 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
• Patient Sex: Unknown