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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 33600030
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Device was not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the adjustment block seized up during the surgical procedure.The surgeon attempted to loosen the adjustment block with a screwdriver but broke the screwdriver.A 2nd set of instruments was pulled for the surgery to complete the case.There was a 20 minute delay to the case resulting in the patient having additional anesthesia.No patient complications were reported.
 
Manufacturer Narrative
Correction: h4, h6 health impact, results codes.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual inspection: visual examination finds normal wear and tear of a reusable device.Functional inspection: functional examination of the returned part confirms the proximal/distal adjustment lockout is jammed.Due to the nature of the complaint, a dimensional inspection was not considered necessary.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to improper usage of the adjustment block either in the previous surgeries or during the cleaning and sterilization.The pin lock knob is reverse-threaded which may have led to over-tightening and jamming the knob.If the user tried to loosen the knob in the normal direction the action would only increase the jamming effect.The surgical technique does not indicate that the knob is reverse threaded but there are standard lock and unlock icons with directional arrows on the pin lock knob to indicate which direction to turn the knob.The ifu clearly instructs the user that: the current package insert for instruments does state, "care must be taken to avoid compromising their exacting performance." the insert also includes maintenance recommendations which states, "for devices with hinged/mating surfaces or moving components, a biocompatible, surgical-grade lubricant intended for heat sterilized medical instruments should be used per the manufacturer's guidelines¿ and "inspect the instrument case and instruments for damage when received and after each use and cleaning." if any further information is provided, the complaint report will be updated.
 
Event Description
It was reported that the adjustment block seized up during the surgical procedure.The surgeon attempted to loosen the adjustment block with a screwdriver but broke the screwdriver.A 2nd set of instruments was pulled for the surgery to complete the case.There was a 20 minute delay to the case resulting in the patient having additional anesthesia.No patient complications were reported.
 
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Brand Name
INFINITY TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
MDR Report Key11815520
MDR Text Key251422762
Report Number0001043534-2021-00080
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K123954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number33600030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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