MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALORSUBTALAR OUTRIGGER GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	4150011002
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the welded screws often break and then there isn¿t enough tension in the handle to get the adaptor off.The targeting guide slowly becomes out of alignment due to the heat from sterilization and the pounding and torque of the jig.Secondly, some green letters on the jig and some with orange when in position 3 miss the subtalar screw every time.No additional information is available.
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 on a supplemental report.

• Brand Name: VALORSUBTALAR OUTRIGGER 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: 16702170
• Report Number: 3010667733-2023-00177
• Device Sequence Number: 3629292
• Product Code: FZX
• UDI-Device Identifier: 00889797035552
• UDI-Public: 00889797035552
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/07/2023

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: 4150011002
• Device Catalogue Number: 4150011002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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