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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 38MM REAMER MODULAR, CANNULATED
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EXACTECH, INC. EQUINOXE; NARROW REV 38MM REAMER MODULAR, CANNULATED Back to Search Results
Catalog Number 321-55-38
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
Pending evaluation.
 
Event Description
It was reported that the surgeon put a bow tie reamer on a modular handle (on drill not ream).Put it over a k wire and ran it down to the glenoid.Started to ream the glenoid and the piece that attaches to the handle sheared off.It did end up notching the glenoid but we were able to facilitate the baseplate on without complications.
 
Manufacturer Narrative
(h3) the broken reamer reported was likely the result of applying a force greater than yield strength of the material and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate failure.However, this cannot be confirmed because the component was not returned for evaluation.(h6) evaluation codes: 2199, 1069.
 
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Brand Name
EQUINOXE
Type of Device
NARROW REV 38MM REAMER MODULAR, CANNULATED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9257092
MDR Text Key170237116
Report Number1038671-2019-00548
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862232762
UDI-Public10885862232762
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 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number321-55-38
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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