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

Catalog Number	301-05-01
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 capa (b)(4).
Event or Problem Description
As reported, during a procedure, the surgeon was handed the preserve broach handle to begin broaching and felt a sharp piece of metal pierce his gloves.Upon inspection of the handle, he noticed there was defect on the left side next to the retroversion inserts.Handle couldn't be used for the remainder of the case, so we opened a backup preserve tray.He inspected that handle and noted a similar defect, not quite as severe, in the same weak spot of the second handle.Sharp, protruding metal on the left side next to the retroversion inserts.Patient was last known to be in stable condition following the event.Device will be returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Based upon the facts that are known at the time of evaluation, 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.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 following sections were updated: d1, h6.The following sections were corrected: d1, h6.Based upon the facts that are known at the time of evaluation, 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.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: 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: kate jacobson ; 3523771140
• MDR Report Key: 11559985
• Report Number: 1038671-2021-00128
• Device Sequence Number: 4766522
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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
• Device Lot Number: 85005005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 02/17/2025; 02/17/2025
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 03/12/2025; 03/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male