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

Catalog Number	301-03-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 301-07-10, 83435010 - prm stm insrtr extrct.
Event or Problem Description
As reported, during removal of trial stem the surgeon hit the version bar that was on the stem extractor causing it to shear off.All parts were removed from the patient and nothing was left inside.Device will return.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations and the reported event, the broken retroversion handle reported was likely the result of impacting the junction between the primary stem inserter/extractor and retroversion handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion handle, leading to ultimate failure.
Additional Manufacturer Narrative
Section h10: based on historical complaint investigations, the returned devices, and the reported event, the broken retroversion handle reported was likely the result of impacting the junction between the primary stem inserter/extractor and retroversion handle, allowing for the applied force to be transmitted to the threaded tip of the retroversion handle, leading to ultimate failure.The fractured black plastic sphere on the primary stem inserter/extractor was likely the result of a stress riser which led to crack initiation, propagation, and ultimate fracture secondary to years of normal surgical use for impaction and subsequent reprocessing and sterilization cycles.

• Brand Name: EQUINOXE
• Common Device Name: RETROVERSION HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11364438
• Report Number: 1038671-2021-00064
• Device Sequence Number: 2660659
• 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,Followup
• Report Date (Section B): 07/20/2021

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: 301-03-10
• Device Lot Number: 69697002
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 06/30/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/13/2021; 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention