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

Model Number	RETROVERSION HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during implantation of the humeral stem the retroversion rod thread snapped and became detached.Both pieces easily recovered.No patient impact.Devices to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken retroversion handle reported was likely the result of impacting the strike surface of the broach handle with the threads of the retroversion handle partially engaged, allowing for the applied force to be transmitted to the threaded tip of the device, 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: 10375763
• Report Number: 1038671-2020-00381
• Device Sequence Number: 14124956
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/11/2020

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 Model Number: RETROVERSION HNDL
• Device Catalogue Number: 301-03-10
• Device Lot Number: 49082003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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