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

Catalog Number 301-05-01

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during the impaction of a preserve stem broach, the doctor suddenly stopped and had a piece of the broach handle in his hand.The piece came off the side of the broach handle, not the broach.He did not believe that there was a retractor pressing against the broach handle at the time of impaction.He removed the piece of metal, and continued to impact to the next size broach, using the same broach handle with no issues.He finished the case with the same broach handle and had no other issues.I am returning the broach handle for further inspection.The piece of the broach handle broke, fell into the patient, and then removed by the doctor by hand.We had to examine the piece to ensure it was from the broach handle and that everything was removed properly.Patient was last known to be in stable condition following the event.The device will be returned.

Manufacturer Narrative

Section h10: (h3) per the hhe, the most probable root cause of the reported event is design-related.The handle body subcomponent 301-300- 01 is a single body construction.However, the bridge feature that is fracturing is relatively thin (.035) and thus potentially susceptible to fracture.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE II BROACH HANDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11364436
• MDR Text Key: 233020915
• Report Number: 1038671-2021-00065
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301-05-01
• Device Lot Number: 264005002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention