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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jig was not aligning correctly.The surgical team did an alignment check before the case started and the drill was not properly going through the nail when locked in ¿position 3¿ and attempting the left subtalar screw.The outrigger guide did not seem to aim the drill directly through the center of the hole, it was coming into contact with the nail itself, just above the hole.The surgeon fiddled around with it and managed to get it to work outside of the patient but when inside the patient the alignment was disrupted again and the surgeon was not able to place the subtalar screw.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: visual examination shows scratches and deformations consistent with reusable devices.A functional test was performed with the instrument conforming to specifications.The targeting guide was found to align properly with a 10mm x 150mm valor nail (size of valor nail used for this case) after setting the instrument to position 3.Different sized valor nails were also assembled and found to align properly with the targeting guide.A drill bit was successfully passed through the both the targeting guide and the valor nail with no issues noted.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.
Event or Problem Description
It was reported that the jig was not aligning correctly.The surgical team did an alignment check before the case started and the drill was not properly going through the nail when locked in ¿position 3¿ and attempting the left subtalar screw.The outrigger guide did not seem to aim the drill directly through the center of the hole, it was coming into contact with the nail itself, just above the hole.The surgeon fiddled around with it and managed to get it to work outside of the patient but when inside the patient the alignment was disrupted again and the surgeon was not able to place the subtalar screw.

• 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: 15805929
• Report Number: 3010667733-2022-00386
• Device Sequence Number: 5472107
• Product Code: FZX
• UDI-Device Identifier: 00889797035552
• UDI-Public: 00889797035552
• 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): 02/09/2023

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: 1793166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2018
• 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