MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STEM AND TRAY INSERTER

Catalog Number	321-07-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon was removing the broach when the rod snapped off.Surgeon did not hit version rod in process.Threaded end of the rod was sheered off in broach handle.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 84283012 (h3) based on previous similar complaint investigation and the returned device, the broken instrument reported was likely the result of impacting near the junction between the stem inserter (321-07-00) and the retroversion handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion handle, leading to ultimate failure.

• Brand Name: EQUINOXE
• Common Device Name: STEM AND TRAY INSERTER
• 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: 11914084
• Report Number: 1038671-2021-00259
• Device Sequence Number: 3540940
• Product Code: LXH
• UDI-Device Identifier: 10885862243034
• UDI-Public: 10885862243034
• 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
• Report Date (Section B): 04/14/2022

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: 321-07-00
• Device Lot Number: 84283012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 04/14/2022
• 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: Unknown