MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RETROVERSION HNDL

Catalog Number	301-03-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the retroversion handle snapped off stem inserter/extractor due to being struck by mallet by doctor.The threaded bit is still in left side of inserter.No pieces except what was stuck in the handle.No delay.Device will return for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported was likely the result of directly impacting the retroversion bar while engaged with the broach handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion bar, leading to ultimate failure.

• Brand Name: EQUINOXE
• Common Device Name: RETROVERSION HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11640341
• Report Number: 1038671-2021-00163
• Device Sequence Number: 3051802
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 301-03-10
• Device Lot Number: 307331001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/21/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention