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

Catalog Number	4150011000
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the target device jammed and could not turn to nr 1, 2 or 3.The operation was delayed approximately 20 min.The surgeon used a hammer and other instruments to release the trigger.
Additional Manufacturer Narrative
Correction h6 method code.The complaint could not be confirmed; indeed, the product was returned for evaluation, but it does not matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the received instrument shows scratches, dents and deformation, from use.Furthermore, at the cylindric section a slight adhesive foreign substance is visible, this does not have any impact to the function of the instrument.Functional examination of the received product shows that the received instrument does function as intended, as it got tested with a left and right connector.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the target device jammed and could not turn to nr 1, 2 or 3.The operation was delayed approximately 20 min.The surgeon used a hammer and other instruments to release the trigger.

• 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: 19760679
• Report Number: 3010667733-2024-00446
• Device Sequence Number: 8513533
• Product Code: FZX
• UDI-Device Identifier: 00889797035545
• UDI-Public: 00889797035545
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 09/25/2024

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: 2889594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• 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