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

Catalog Number 321-45-38

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The surgeon went to use the 38mm pilot tipped butterfly reamer on the tri-drive handle and jacobs t-handle and located the pilot tip in the previously drilled hole.Upon turning the reamer a quarter of a turn, the pilot tipped snapped off inside the glenoid.The surgeon spent the next 45 minutes trying to get the pilot tip out of the glenoid by trying various methods but was unable to do so and ended up pushing it further in.In the end, he accepted that he would have to leave it inside the patient.

• 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
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8517679
• MDR Text Key: 142053015
• Report Number: 1038671-2019-00249
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862232724
• UDI-Public: 10885862232724
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 321-45-38
• Device Lot Number: 123142005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR