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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
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pending evaluation.
 
Event or Problem Description
It was reported that the pilot tip came off.
 
Additional Manufacturer Narrative
(h3) based on capa2017-12, the broken devices reported was likely the result of applying a bending moment to the reamers during use, which led to brittle fractures of the pilot tip feature.(h6) evaluation codes: 2199, 1069.(h7) recall.(h9) correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2667-2017, z-2668-2017.
 
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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 Key9207514
Report Number1038671-2019-00520
Device Sequence Number2450839
Product Code LXH
UDI-Device Identifier10885862087621
UDI-Public10885862087621
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
UNK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 03/24/2020
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 Number321-25-38
Device Lot Number99475007
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/01/2019
Supplement Date Received by Manufacturer03/18/2020
Initial Report FDA Received Date10/18/2019
Supplement Report FDA Received Date03/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		SEE H10
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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