MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC RESECTION ADJUSTMENT BLOCK INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33600030
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
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 noticed the resection adjustment block wouldn't translate proximal distal at the end of the procedure.The purple knob is locked and won¿t really turn with significant force applied.
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: examination of the returned device finds normal wear and tear typical for a reusable device that has been in service for years.There is damage/deformation to the lockout screws and the recesses of the adjustment knobs.Examination of the proximal/distal knob, shaft thread and spring did not find any notable damage or obstructions.Attempts to rotate the proximal/distal knob found the knob jammed in the returned state.Lubricant was applied to the threading and recesses of the knob and threaded shaft.Force was applied to the knob and the jam released.The knob was able to move from the most proximal and distal positions without obstruction.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿use medical devices in accordance with their labeled indications and wright¿s instructions for use, especially during insertion and removal.Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.If the device is damaged, retain it to assist with wright¿s analysis of the event.For devices with hinged/mated surfaces or moving components, a biocompatible, surgical grade lubricant intended for heat sterilized medical instruments (miltex® spray lubrication or equivalent) should be used per the manufacturer¿s guidelines.Apply spray lubricant to the moving components and/or hinged/mated components where appropriate prior to the sterilization process.¿.Based on investigation, the root cause was attributed to a user related issue i.E.Customer-improper preparation of (re)use.The failure was caused due to not applying enough lubricant to the device resulting in jamming.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was noticed the resection adjustment block wouldn't translate proximal - distal at the end of the procedure.The purple knob is locked and won¿t really turn with significant force applied.

• Brand Name: RESECTION ADJUSTMENT BLOCK INFINITY TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 15195593
• Report Number: 3010667733-2022-00268
• Device Sequence Number: 17534373
• Product Code: HSN
• UDI-Device Identifier: 00889797004008
• UDI-Public: 00889797004008
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123954
• 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): 12/05/2022

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: 33600030
• Device Catalogue Number: 33600030
• Device Lot Number: 1333532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2014
• 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