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

Catalog Number	321-55-38
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the surgeon put a bow tie reamer on a modular handle (on drill not ream).Put it over a k wire and ran it down to the glenoid.Started to ream the glenoid and the piece that attaches to the handle sheared off.It did end up notching the glenoid but we were able to facilitate the baseplate on without complications.
Additional Manufacturer Narrative
(h3) the broken reamer reported was likely the result of applying a force greater than yield strength of the material and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate failure.However, this cannot be confirmed because the component was not returned for evaluation.(h6) evaluation codes: 2199, 1069.

• Brand Name: EQUINOXE
• Common Device Name: NARROW REV 38MM REAMER MODULAR, CANNULATED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9257092
• Report Number: 1038671-2019-00548
• Device Sequence Number: 14005827
• Product Code: KWT
• UDI-Device Identifier: 10885862232762
• UDI-Public: 10885862232762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 321-55-38
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention