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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR CNLTD TRIDRV DRVR
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EXACTECH, INC. EQUINOXE; MDLR CNLTD TRIDRV DRVR Back to Search Results
Catalog Number 315-25-00
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/12/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pending evaluation.
 
Event or Problem Description
As reported, prior to use it was noted that the collar/spring came loose.Unsure when this happened.Patient was last known to be in stable condition following the event.Device will return for evaluation.
 
Additional Manufacturer Narrative
(h3) the disassembled tri-drive handle reported in was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the modular cannulated tri-drive shaft becoming deformed as a result of holding the sleeve stationary while reaming.
 
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Brand Name
EQUINOXE
Common Device Name
MDLR CNLTD TRIDRV DRVR
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key11451618
Report Number1038671-2021-00101
Device Sequence Number11643716
Product Code LXH
UDI-Device Identifier10885862085313
UDI-Public10885862085313
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
UNK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number315-25-00
Device Lot Number128491030
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 02/17/2021
Supplement Date Received by Manufacturer04/08/2021
Initial Report FDA Received Date03/10/2021
Supplement Report FDA Received Date04/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNK.
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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