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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 Consequences Or Impact To Patient (2199)
Date of Event 08/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation approval date: 16-sep-2020 per (b)(4), 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.
 
Event or Problem Description
As was reported, this instrument was found to be broken during set up.It was not used on a patient.There was no surgical delay.Patient was last known to be in stable condition following the event.Device will be returned.
 
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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 Key10936897
Report Number1038671-2020-00633
Device Sequence Number3186168
Product Code LXH
UDI-Device Identifier10885862085313
UDI-Public10885862085313
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
UNK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/02/2020
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/16/2020
Initial Report FDA Received Date12/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age77 YR
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