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

Model Number	4150011002
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the targeting guide was not moving appropriately into the third position, it would not click into place.The subtalar guide also has issues with the inner locking knob sliding in and out.Subtalar screw missed the hole in the nail.It had to be taken out and inserted free-hand due to jig not in correction place.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the instrument ¿valor targeting guide¿ showed, that based on the broken spring the locking mechanism does not function as intended anymore, as the handle does not automatically get pushed back after use and the rotation get locked, otherwise the instrument is still working as intended.The broken off piece of the spring is missing as it didn¿t got returned.Furthermore, the instrument is in a well used condition with scratches, dents and deformation.The deformations are a result from hammer blows.The marking on the instrument is slightly fading.The instrument ¿valorsubtalar outrigger guide¿ shows scratches, dents and deformation from use.The locking rivets appear to be missing allowing the cylinder to spin freely and move in and out of the recess.Despite the defects in the returned instruments, it is possible to assemble them together.The current instrument instructions for use state: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling." 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.Based on investigation, the root cause was attributed to wear and tear from often use over the years, end of life.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the targeting guide was not moving appropriately into the third position, it would not click into place.The subtalar guide also has issues with the inner locking knob sliding in and out.Subtalar screw missed the hole in the nail.It had to be taken out and inserted free-hand due to jig not in correction place.

• 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: 14000502
• Report Number: 3010667733-2022-00148
• Device Sequence Number: 4453188
• Product Code: FZX
• UDI-Device Identifier: 00889797035552
• UDI-Public: 00889797035552
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 793195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2010
• 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