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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE TORQUE SCREW
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EXACTECH, INC EQUINOXE TORQUE SCREW Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)
Patient Problem No Code Available (3191)
Event Date 06/27/2016
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Manufacturer Narrative
The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
Revision due to glenoid loosening and cuff tear.
 
Event Description
Revision due to glenoid loosening and cuff tear.
 
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Brand Name
EQUINOXE TORQUE 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 Key5829244
MDR Text Key51295484
Report Number1038671-2016-00459
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
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 08/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
Patient Age78 YR
Patient Weight63
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