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

Catalog Number	4150011003
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "we used the valor for the first time and had difficulty with the guide jig.The culprit was the damaged spring inside of the nail attachment.Attachment to the nail (left) was not allowing the nail to turn to the different positions to drill the screws.We managed to complete the operation but only by removing the damaged spring in the device.We noticed this during the surgery because it is essential to the operation." the procedure was delayed by 60 minutes.
Additional Manufacturer Narrative
Corrections: please refer to section h6 device and results codes.The reported event could be confirmed since an image was provided and matches the alleged failure mode.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned.However, an image was provided showing the removed spring which appears visibly deformed.For further evaluation, the device will need to be returned.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "we used the valor for the first time and had difficulty with the guide jig.The culprit was the damaged spring inside of the nail attachment.Attachment to the nail (left) was not allowing the nail to turn to the different positions to drill the screws.We managed to complete the operation but only by removing the damaged spring in the device.We noticed this during the surgery because it is essential to the operation." the procedure was delayed by 60min.

• Brand Name: VALOR GUIDE CONNECTOR LEFT
• 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: 20666944
• Report Number: 3010667733-2024-00862
• Device Sequence Number: 18202133
• Product Code: FZX
• UDI-Device Identifier: 00889797035569
• UDI-Public: 00889797035569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 4150011003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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