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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 42MM REAMER MODULAR, CANNULATED
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EXACTECH, INC. EQUINOXE; NARROW REV 42MM REAMER MODULAR, CANNULATED Back to Search Results
Catalog Number 321-55-42
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
Pending evaluation.
 
Event Description
As reported, during a procedure on a male patient, as the reamer was being taken off modular driver after reaming was finished the tip broke into 2 pieces.No parts or pieces fell into the wound site.There was no surgical delay.Patient was last known to be in stable condition following the event.Device to be returned.
 
Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of applying a counter clockwise resistance force to the instrument greater than yield strength of the material and subsequent sterilization cycles, which led to crack initiation, propagation, and ultimate failure.
 
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Brand Name
EQUINOXE
Type of Device
NARROW REV 42MM REAMER MODULAR, CANNULATED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key10859768
MDR Text Key219763049
Report Number1038671-2020-00620
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862232779
UDI-Public10885862232779
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number321-55-42
Device Lot Number123142028
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK.
Patient Outcome(s) Hospitalization; Required Intervention;
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