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 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, while reaming on this (b)(6) y/o male, the pilot tip reamer broke off.Tip was recovered but disposed of.Patient was last known to be in stable condition following the event.Device to be returned.

Manufacturer Narrative

Section h10: (d4) lot number: 60931024.(h3) based on capa2017-12, 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.(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-2668-2017, z-2668-2017.

• Brand Name: EQUINOXE
• Type of Device: MDLR RV RMR 38MM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559669
• MDR Text Key: 207704390
• Report Number: 1038671-2020-00535
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087621
• UDI-Public: 10885862087621
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-38
• Device Lot Number: 60931024
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2020
• 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
• Patient Age: 63 YR