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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP
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EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP Back to Search Results
Catalog Number 321-25-38
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 10/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pending evaluation.
 
Event or Problem Description
It was reported that while glenoid reaming with the 38mm-pilot tip reamer, the pilot tip has broken off the reamer.
 
Additional Manufacturer Narrative
Section h10: (h3) based on capa2017-12, the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.(h6) evaluation codes: 2199, 1069.
 
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Brand Name
EQUINOXE
Common Device Name
MDLR RV RMR 38MM PLT TIP
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9264671
Report Number1038671-2019-00551
Device Sequence Number16238712
Product Code KWT
UDI-Device Identifier10885862087621
UDI-Public10885862087621
Combination Product (Y/N)N
Initial Reporter CountryAS
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,Followup
Report Date (Section B) 10/31/2019
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 Number321-25-38
Device Lot Number123142021
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 10/17/2019
Supplement Date Received by Manufacturer01/07/2020
Initial Report FDA Received Date10/31/2019
Supplement Report FDA Received Date01/09/2020
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;
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