MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ADJUST REV SCRW DRILL GD

Catalog Number	321-19-05
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): drill bit.
Event or Problem Description
As reported, during a procedure on this (b)(6) male patient, the drill bit seized and got stuck in drill guide while drilling screws in glenoid plate, the drill bit broke and is stuck in drill guide.This event is for the drill guide.No impact to patient, and no delay to surgery as back up instruments were readily available.Patient was last known to be in stable condition following the event.Devices to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the jammed devices reported in case-2021-00003530 likely the result of deformation on the inner surface of the drill guide and outer surface of the drill bit, which led to galling and eventually prevented the drill bit from passing through.The broken drill bit was likely the result of applying a bending moment while drilling, which led to ultimate fracture of the device.

• Brand Name: EQUINOXE
• Common Device Name: ADJUST REV SCRW DRILL GD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11404233
• Report Number: 1038671-2021-00081
• Device Sequence Number: 3545204
• Product Code: LXH
• UDI-Device Identifier: 10885862580733
• UDI-Public: 10885862580733
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/02/2021

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: 321-19-05
• Device Lot Number: 285698001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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
• Patient Age: 80 YR