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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR PRM RMR LG PLT TIP
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EXACTECH, INC. EQUINOXE; MDLR PRM RMR LG PLT TIP Back to Search Results
Catalog Number 315-25-14
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
 
Event or Problem Description
As reported, during a procedure on a male patient, the reamer broke while reaming the glenoid.All pieces we retrieved and verified by x ray.No time was added to the case and the patient wasn¿t harmed.Patient was last known to be in stable condition following the event.Device to be returned.
 
Additional Manufacturer Narrative
Section h10: (h3) the broken reamer reported was likely the result of the reamer experiencing high loads possibly during off-axis reaming and/or contact with hard bone which led to brittle fracture of the blades.
 
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Brand Name
EQUINOXE
Common Device Name
MDLR PRM RMR LG PLT TIP
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key11404696
Report Number1038671-2021-00086
Device Sequence Number3545206
Product Code LXH
UDI-Device Identifier10885862085368
UDI-Public10885862085368
Combination Product (Y/N)N
Initial Reporter StateMO
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) 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number315-25-14
Device Lot Number99774032
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 02/11/2021
Supplement Date Received by Manufacturer03/12/2021
Initial Report FDA Received Date03/03/2021
Supplement Report FDA Received Date04/01/2021
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;
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