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

Catalog Number 321-25-38

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that while glenoid reaming with the 38mm-pilot tip reamer, the pilot tip has broken off the reamer.

Manufacturer Narrative

Section h10: (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.(h6) evaluation codes: 2199, 1069.

• 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: 9264671
• MDR Text Key: 189076491
• Report Number: 1038671-2019-00551
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-38
• Device Lot Number: 123142021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention