MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	531-55-26
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder procedure, a 3.2 pin was deformed due to a hard glenoid bone and could not come back though the guide.When forced by power, it became lodged in cannulation.There was a breakage of device, but no fragments, parts, or pieces fell into the wound or the patient.There was a surgical delay reported with no adverse event to the patient.The patient was last known to be in stable condition following the event.The device is available for return.An image of the device was provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h1 - upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: EQUINOXE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 20536156
• Report Number: 1038671-2024-04131
• Device Sequence Number: 17817032
• Product Code: OLO
• UDI-Device Identifier: 10885862578198
• UDI-Public: 10885862578198
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162567
• 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,Followup
• Report Date (Section B): 07/29/2025

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: 531-55-26
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 07/29/2025
• 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 Age: 58 YR
• Patient Sex: Male