MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 42MM PLT TIP

Model Number	MDLR RV RMR 42MM PLT TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon put too much angle and torque on them and snapped the point off both instruments.The patient was an older male of average build.No pieces fell into the wound.All available information received.
Additional Manufacturer Narrative
(h3) based on capa2017-12, the broken devices reported were likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.(h7) recall.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2667-2017, z-2668-2017.Section h11: the following sections have corrected information: (d4) model number: na.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RV RMR 42MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9641855
• Report Number: 1038671-2020-00015
• Device Sequence Number: 2474618
• Product Code: LXH
• UDI-Device Identifier: 10885862087638
• UDI-Public: 10885862087638
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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 Model Number: MDLR RV RMR 42MM PLT TIP
• Device Catalogue Number: 321-25-42
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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 Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention