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

Catalog Number 321-45-38

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event 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.

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
• Type of Device: NARROW REV 38MM REAMER MODULAR, PILOT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9465892
• MDR Text Key: 189078959
• Report Number: 1038671-2019-00604
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862232724
• UDI-Public: 10885862232724
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 321-45-38
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention