MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 38MM REAMER MODULAR, PILOT TIP

Catalog Number	321-45-38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, a bowtie reamer pilot-tip broke off while on the mayo stand, outside of the patient.The cause of the break was not obvious.The patient was unaffected.
Additional Manufacturer Narrative
Section h10: (h3) per capa: 2017-12, the risk documentation was lacking specific failures for this type of defect for these instruments.In addition, the surgical technique was not providing information to the user of the instrument that reaming off axis can damage or break the instruments.Additionally, the surgical technique did not provide adequate instruction to the user.In this case, due to the tip on the device being found fractured on the back table prior to use in the reported surgery, it is likely that the tip was damaged during a previous surgery and subsequent reprocessing and handling resulted in the propagation and ultimate fracture of the pilot tip.(h9) z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2667-2017, z-2668-2017.

• Brand Name: EQUINOXE
• Common Device Name: NARROW REV 38MM REAMER MODULAR, PILOT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9465892
• Report Number: 1038671-2019-00604
• Device Sequence Number: 3104165
• Product Code: KWT
• UDI-Device Identifier: 10885862232724
• UDI-Public: 10885862232724
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 321-45-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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