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

Catalog Number	301-05-01
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6.The complaint device was evaluated, and the reported event was confirmed.The evaluation identified.(high level observation that led them to associate the device with the capa: " the instrument was fracture").A definitive root cause was unable to be determined at this time; however, further investigation into the reported event is being conducted through our capa process.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The complaint device was evaluated, and the reported event was confirmed.The evaluation identified.(high level observation that led them to associate the device with the capa: " the instrument was fracture").A definitive root cause was unable to be determined at this time; however, further investigation into the reported event is being conducted through our capa process.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE II BROACH HANDL
• Common Device Name: EQUINOXE II BROACH HANDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11364436
• Report Number: 1038671-2021-00065
• Device Sequence Number: 2660660
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 301-05-01
• Device Lot Number: 264005002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/19/2021; 02/17/2025; 02/17/2025
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/16/2021; 03/13/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female