MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	321-25-42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, surgeon lost control of the power tool during reaming process causing the reamer tip to bend within the glenoid and snap off.The event is not associated with the revision of exactech implants.The event is related to the breakage of the device.Fragments, parts or pieces fell into the patient and were not removed.The surgeon was unable to remove the broken reamer tip.Surgeon took an x-ray to ensure the metal tip was within bone and not soft tissue.The event led to a 15-30 min surgical delay to attempt to remove the part and take an x-ray.Patient was last known to be in stable condition following the event.No patient/medical information provided.Unable to obtain images or x-rays.Product available for return.
Additional Manufacturer Narrative
H3: the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip feature.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19620958
• Report Number: 1038671-2024-02161
• Device Sequence Number: 8205175
• Product Code: HSD
• UDI-Device Identifier: 10885862087638
• UDI-Public: 10885862087638
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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 Catalogue Number: 321-25-42
• Device Lot Number: 99777011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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: Required Intervention
• Patient Sex: Unknown