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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
Model Number 33600030
Device Problem Use of Device Problem
Event Date 08/18/2018
Event Type  Injury  
Manufacturer Narrative

The device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description

Allegedly, the locking screw does not lock. This is the locking screw for the superior/inferior movement of the jig. This adjustment block part was brand new and was not damaged during use, it simply did not lock. First time it was in a case. No impact to patient.

 
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Brand NameINFINITY TOTAL ANKLE SYSTEM
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis , TN 38117
9014516318
MDR Report Key7912232
Report Number1043534-2018-00150
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number33600030
Device LOT Number1602159
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/29/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2018
Event Location Hospital
Date Manufacturer Received11/20/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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