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

Model Number	SMALL STEM PROTECTOR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a641424 300-30-06 - equinoxe preserve stem 6mm.A781399 320-10-00 - equinoxe reverse tray adapter plate tray +0.A562951 320-15-05 - eq rev locking screw.A652595 320-20-00 - eq reverse torque defining screw kit.S479699 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.A758168 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.A737718 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.S277091 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm.A353661 320-31-40 - glenosphere, 40mm.A656268 320-35-07 - small superior/posterior aug glenoid plate,left.7241820 320-40-00 - 145-deg pe 40mm hum liner +0.A769138 321-52-09 - 3.2mm k-wire, trocar tip.A595664 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6), 2023.During the course of the initial surgery, the humeral head protector disassociated from the trial preserve stem.The event was not noticed.The disassociated humeral head protector moved posterior to the glenoid and was therefore not visible from the incision.The surgery was completed successfully, however the device component remained in the shoulder which the surgeon became aware of during a review of post operative x-rays.There was an instrument count completed prior to wound closure, but this instrument was not included in the count.The revision surgery was completed to remove the instrument.The glenosphere, tray, and liner were exchanged, and the humeral head protector was successfully removed.Removing the device caused a greater than 45-minute surgical delay/prolongation during the procedure.There was no adverse event to the patient as a result.No patient information, x-rays or images were provided.The device is available for return.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following fields were updated: h6.The following fields were corrected: b1, b2, b3, d9.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18576347
• Report Number: 1038671-2024-00127
• Device Sequence Number: 7923244
• Product Code: LXH
• UDI-Device Identifier: 10885862580405
• UDI-Public: 10885862580405
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/22/2025

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 Model Number: SMALL STEM PROTECTOR
• Device Catalogue Number: 301-08-21
• Device Lot Number: 285700027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 10/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male