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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY
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EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY Back to Search Results
Catalog Number 320-10-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
Event Type  Injury  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.
 
Event Description
Patient reports acromial tenderness.The case report form indicates the event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.
 
Event Description
Index surgery: (b)(6) 2016.Patient reports acromial tenderness on (b)(6) 2016.Post-op scapular fracture reported on (b)(6) 2016.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the acromial tenderness reported was likely the result of the scapular fracture that was not detected until a later appointment.
 
Event Description
Index surgery: (b)(6) 2016.Patient reports acromial tenderness on (b)(6) 2016.Post-op scapular fracture reported on (b)(6) 2016.This event report was received through clinical data collection activities.
 
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Brand Name
EQUINOXE REVERSE HUMERAL ADAPTER TRAY
Type of Device
HUMERAL ADAPTER TRAY
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 Key6145927
MDR Text Key61467583
Report Number1038671-2016-00829
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number320-10-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2016
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 Age68 YR
Patient Weight64
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