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 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, the pilot tip broke off of the reamer while reaming the glenoid, all pieces were removed from the wound and the patient was stable leaving the or.Pictures of the device to be sent.No other information available at this time.

Manufacturer Narrative

Section h10: (h3) based on capa2017-12, the broken device reported was likely the result of applying a bending moment to the reamers during use, which led to brittle fractures of the pilot tip feature.(h7) recall (h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z2663-2017, z2664-2017, z2665-2017, z2666-2017, z2667-2017, z2668-2017.*no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d6, d7, d11, g5, g8, h4, h7.

• 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: 9480210
• MDR Text Key: 189079162
• Report Number: 1038671-2019-00606
• 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: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• 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: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention