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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY RESECTION ADJUSTMENT BLOCK SMALL JOINT INSTRUMENT

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY RESECTION ADJUSTMENT BLOCK SMALL JOINT INSTRUMENT Back to Search Results
Catalog Number 3360-0030
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2016
Event Type  Injury  
Manufacturer Narrative
The investigation is not complete. Additional information has been requested. Trends will be evaluated. This report will be updated when the investigation is complete.
 
Event Description
Allegedly, surgeon had to abort the total ankle arthroplasty surgical procedure due to the adjustment block malfunctioning. The proximal and distal adjustment knobs froze and we were not able to manipulate the sizing guide into the correct position.
 
Manufacturer Narrative
This incident is considered closed. If at any time new or updated information becomes available, the incident will be re-opened and investigated.
 
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Brand NameINFINITY RESECTION ADJUSTMENT BLOCK
Type of DeviceSMALL JOINT INSTRUMENT
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
901451-631
MDR Report Key5742690
MDR Text Key47962285
Report Number1043534-2016-00044
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3360-0030
Device Lot Number131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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