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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE TORQUE DEFINING SCREW
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EXACTECH, INC EQUINOXE TORQUE DEFINING SCREW Back to Search Results
Catalog Number 300-11-00
Device Problems Degraded (1153); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2016
Event Type  malfunction  
Manufacturer Narrative
Pending engineering evaluation.
 
Event Description
A total anatomic shoulder was converted to a reverse due to rotator cuff degradation.
 
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of rotator cuff degradation.The surgeon had "no reported issues" with the components.
 
Event Description
A total anatomic shoulder was converted to a reverse due to rotator cuff degradation.
 
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Brand Name
EQUINOXE TORQUE DEFINING SCREW
Type of Device
SCREW
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key5750779
MDR Text Key48747425
Report Number1038671-2016-00399
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number300-11-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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