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	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, a broken version rod with the threads gone was discovered when picking up instruments from processing.Specific case and patient information is unknown.Device to be returned.
Additional Manufacturer Narrative
(h3) the broken instrument reported was likely the result of transmitted impaction forces to the junction between the broach handle and retroversion handle with the threads of the retroversion handle partially engaged, 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: RETROVERSION HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11153730
• Report Number: 1038671-2021-00003
• Device Sequence Number: 17173103
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/13/2021

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: 51366029
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention