MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; TEMPLATE

Catalog Number	309-10-25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision procedure of a right-side shoulder due to a fracture of implants, a prong on the 25 hrp middle segment broke off while disengaging from the proximal body trial.No parts or pieced fell into the wound site.There were no surgical delays during the procedure.The (b)(6) yo male patient was last known to be in stable condition during the event.X-rays were provided.The fractured trial is available for return.An image of the broken trial was provided.No further information.

• Brand Name: EQUINOXE
• Common Device Name: TEMPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20000732
• Report Number: 1038671-2024-02919
• Device Sequence Number: 20072059
• Product Code: HWT
• UDI-Device Identifier: 10885862267719
• UDI-Public: 10885862267719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 309-10-25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male