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

Catalog Number	321-25-01
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It as reported that the physician had difficulty getting the reamer in due to patient anatomy.The tips broke off of each of these reamers.The tips did not remain in the patient and were removed before proceeding.The patient was stable upon leaving the operating room.
Additional Manufacturer Narrative
Section h10: (h3) based on capa2017-12, the broken devices reported were 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) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z2663-2017, z2664-2017, z2665-2017, z2666-2017, z2667-2017, z2668-2017.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RV RMR STRT PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9104366
• Report Number: 1038671-2019-00465
• Device Sequence Number: 16174924
• Product Code: KWT
• UDI-Device Identifier: 10885862087614
• UDI-Public: 10885862087614
• 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): 03/27/2020

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 Number: 321-25-01
• Device Lot Number: 69697018
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 45