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 Codes	Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
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
The adjustment block was not easy to turn the knobs on, when adjusted with screwdriver the green knobs axel bent.
Additional Manufacturer Narrative
Please note the corrections in the h6 health impact code: the reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned device shows scratches and blemishes consistent with reusable instruments.The green part of the knobs appeared to be bent but was found to be broken upon further examination.With the assistance of a screwdriver, a functional test was conducted and the green knobs were found to be broken after the device was unlocked.The violet knob could be turned but with resistance.R&d reviewed the received information and noted the following: "it can be difficult to turn the knobs and can often require a bit of force.One thing i have found is that it is easy enough to be turning the knob(even with a driver) in the wrong direction without knowing it.When fully tightened it takes a bit of force to loosen enough to turn, and so sometimes if a user doesn¿t apply enough force for it to move, they will assume they are turning the wrong way and therefore attempt to turn the other way.Since they believe this new direction is correct, they assume its ¿stuck¿ and apply extra force which is possible that¿s what happened here and therefore it broke.That would be my guess, but it is impossible to tell for sure.The other factor that would go into the likelihood of excessive force being the cause is the lifespan of the device- if it was old and had been through a lot of use and cleaning cycles, then the amount of force it would take to ¿break¿ it would be lower since the part would weaken over time".Based on investigation, the root cause was attributed to a user related issue.The failure was caused by excessive force being applied to the device when turning the green knob.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.The current instructions for use was reviewed and states: "surgical instruments and instrument cases are susceptible to damage from prolonged use and through misuse or rough handling.Care must be taken to avoid compromising their exacting performance." 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
The adjustment block was not easy to turn the nobs on, when adjusted with screwdriver the green nobs axel bent.

• 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: 15611309
• Report Number: 3010667733-2022-00353
• Device Sequence Number: 7179585
• Product Code: HSN
• UDI-Device Identifier: 00889797004008
• UDI-Public: 00889797004008
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 12/27/2022

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: 2433999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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