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

Model Number	4150011000
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
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
It was reported that the valor nail external outrigger was distorted and the valor nail would not align appropriate with the drill guide holes when correctly assembled.It was noticed upon surgeon inspection and attempt to check the drill guides lined up with the screw holes in the nail, visually it was evident that they were incongruent.Additionally, it was reported; the procedure was extended however the length of the extension is unknown.
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: scratches and blemishes consistent with reusable devices can be found all over the instrument.Deformations can be seen at the base of the targeting guide most likely resulting from blows applied with the slap hammer.Key measurements taken were all found to be within dimensional specifications.The length of the metallic arm of the instrument was measured to be 5.769 in.The diameter of the rectangular and circular screw holes was measured to be 0.650 in and 0.453 in respectively.A functional test was performed with the instrument conforming to specifications.The targeting guide was found to align properly with a 10mm x 150mm valor nail after setting the instrument to different positions.Different sized valor nails were also assembled and found to align properly with the targeting guide.A drill bit was successfully passed through the both 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 the valor nail external outrigger was distorted and the valor nail would not align appropriate with the drill guide holes when correctly assembled.It was noticed upon surgeon inspection and attempt to check the drill guides lined up with the screw holes in the nail, visually it was evident that they were incongruent.Additionally, it was reported; the procedure was extended for 10-15 minutes.

• 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: 15872285
• Report Number: 3010667733-2022-00410
• Device Sequence Number: 2454364
• Product Code: FZX
• UDI-Device Identifier: 00889797035545
• UDI-Public: 00889797035545
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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 Model Number: 4150011000
• Device Catalogue Number: 4150011000
• Device Lot Number: 1897061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2018
• 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: Male