MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE II BROACH HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, while broaching the humerus on the patient¿s right shoulder with the broach handle, the surgeon hit the broach handle and noticed something came off.He found a piece of metal had broken off the handle, which was recovered.Patient was last known to be in stable condition following the event.Device will not be returned, however, a picture was sent.
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 potential contributing factors are being investigated in capa2020-62.(h6): heath effect - impact code: 3199, type of investigation: 4114, investigation findings: 3243, investigation conclusion: 12.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: kate jacobson ; 3523771140
• MDR Report Key: 11262513
• Report Number: 1038671-2021-00023
• Device Sequence Number: 3711945
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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: 301-05-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 02/17/2025
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/24/2021; 02/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown