MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE II; BROACH HANDL

Model Number	EQUINOXE II BROACH HANDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure on this (b)(6) y/o male, a piece of metal on the broach broke off into the patient.The piece of metal was recovered during surgical implantation of implants.Had to have an x-ray taken to insure no more metal was inside the patient.Patient was last known to be in stable condition following the event.Device to be returned.There was a delay of 15-30 minutes to take the x-ray and ensure there were no pieces left in the patient.
Additional Manufacturer Narrative
The most likely underlying cause for this broken broach handle reported could not be determined at the time of this investigation.Contributions of instrument reprocessing and surgical use to the sequence of crack initiation, propagation, and ultimate fracture of the metal bridge could not be determined as the device was not available for evaluation.
Additional Manufacturer Narrative
Section h11: d4: serial number has been corrected.

• Brand Name: EQUINOXE II
• Common Device Name: BROACH HANDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559662
• Report Number: 1038671-2020-00534
• Device Sequence Number: 19489874
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE II BROACH HANDL
• Device Catalogue Number: 301-05-01
• Device Lot Number: 124858001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 01/22/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/16/2020; 01/22/2021
• 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: 66 YR