MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR 38MM PLT TIP

Catalog Number 321-25-38

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Based on (b)(4), the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.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-2668-2017, z-2668-2017.

Event Description

As reported the pilot tip on the end of the reamer broke of during the reaming portion of the procedure.The tip was found and we continued to ream with the next size up.This caused no delay, no harm to the patient, and we continued the process with no issues.The patient had no issues related to the procedure.Patient was last known to be in stable condition following the event.The device will return.

• Brand Name: EQUINOXE
• Type of Device: MDLR RV RMR 38MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 11371606
• MDR Text Key: 233248830
• Report Number: 1038671-2021-00068
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-38
• Device Lot Number: 113981018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention