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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 33600030
Device Problem Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
This is a reportable malfunction. The investigation is not complete, this report will be updated when the investigation is complete.
 
Event Description
Adjustment block knob seized.
 
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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 Key5685435
MDR Text Key47231542
Report Number1043534-2016-00034
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123954
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 05/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33600030
Device Lot Number1333532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
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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