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 Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported during a shoulder procedure, while removing broach from humerus, the holding pin in the button of the broach handle came out.All parts were retrieved but the holding pin was lost during the wash cycle.No delay to surgery, second broach handle was used for the remainder of the case.Patient was last known to be in stable condition following the event.Device will be returned.
Additional Manufacturer Narrative
(h3) the broken modular broach handle reported was likely the result of numerous surgical uses and subsequent sterilization cycles, which led to the degradation of the weld at the dowel pin, and ultimately allowed the dowel pin to disassemble while removing the broach from the humeral bone.

• Brand Name: EQUINOXE
• Common Device Name: MDLR BROACH HNDL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10574246
• Report Number: 1038671-2020-00519
• Device Sequence Number: 3033500
• Product Code: LXH
• UDI-Device Identifier: 10885862079619
• UDI-Public: 10885862079619
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/27/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 301-03-01
• Device Lot Number: 117212018
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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