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

Catalog Number	4150011004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a valor targeting handle and guide became stuck together while being assembled in the warehouse.The sales representative noted that the guide could not be detached from the handle after placement in the instrument tray.Both components were brand new and had not been used in any surgical procedures.No patient involvement was reported.
Event or Problem Description
It was reported that a valor targeting handle and guide became stuck together while being assembled in the warehouse.The sales representative noted that the guide could not be detached from the handle after placement in the instrument tray.Both components were brand new and had not been used in any surgical procedures.No patient involvement was reported.
Additional Manufacturer Narrative
Correction: h6 method code, d9 product available to stryker.The reported event was confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the targeting guide and the guide connector were returned disassembled from each other.Visual examination of the returned devices shows visible signs of wear.Scratches and blemishes consistent with reusable instruments can be seen on both devices.Significant deformation and dents were observed at the base of the targeting guide indicating excessive use of the device.The cylindrical interface surface between the targeting guide and the guide connector exhibits extensive wear and abrasion.Functional testing was performed by assembling and disassembling the guide connector with the targeting guide at each position.The guide connector was able to be assembled and disengaged at all three positions.However, during the disassembly, the lever/trigger mechanism was noticeably difficult to depress requiring additional force to disengage the guide connector from the targeting guide.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.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 GUIDE CONNECTOR RIGHT
• 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: 23538657
• Report Number: 3010667733-2025-01340
• Device Sequence Number: 4769852
• Product Code: FZX
• UDI-Device Identifier: 00889797035576
• UDI-Public: (01)00889797035576(11)201218(10)2440138
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/11/2026

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: 4150011004
• Device Lot Number: 2440138
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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