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

Catalog Number	301-03-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
During this female patient¿s initial procedure, while using the broach and broach handle together, the locking button was damaged and fell to the floor.The small stick and spring that the button was attached to could be seen on the floor.We checked with the c-arm just in case of fragments and made sure there were no pieces inside.The operation was replaced by stem trial instead of broach, and there was a slight delay, but the operation was well completed.Patient was last known to be in stable condition following the event.Device will be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken modular broach handle reported was likely the result of a combination of a fractured weld, which was likely due to forcefully removing the dowel pin for cleaning and then reassembling prior to surgery, and an indirect force pathway during impaction.

• Brand Name: EQUINOXE
• Common Device Name: MDLR BROACH HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11618153
• Report Number: 1038671-2021-00154
• Device Sequence Number: 3290976
• Product Code: LXH
• UDI-Device Identifier: 10885862079619
• UDI-Public: 10885862079619
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/10/2021

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: 301-03-01
• Device Lot Number: 47919034
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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