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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33600030
Device Problem Break
Event Date 04/03/2017
Event Type  Malfunction  
Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

 
Event Description

It was reported that the patient underwent an ankle surgery. Allegedly, the locking pin on the back of the resection guide alignment block was broken and would not allow adjustments to be made to the guide. No patient complications were reported.

 
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Brand NameINFINITY®
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer Contact
matthew parrish
1023 cherry road
901451-631
MDR Report Key6600753
Report Number1043534-2017-00055
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number33600030
Device LOT Number1333532
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/04/2017
Event Location Hospital
Date Manufacturer Received05/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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