MAUDE Adverse Event Report: EXACTECH, INC. EQUINOX; SQUARE TORQUE DEFINE SCREW DRIVE KIT

Model Number	300-20-02
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was revised due to the surgeon implanting an anatomic screw in a reverse tray.Anatomic torque screws were then used with reverse humeral trays (one +10 and one +15).
Additional Manufacturer Narrative
Concomitant device(s): 308-02-06, 6962186 - 6x120mm distal stem modular cemented.308-05-17, 6486068 - distal fixation ring ha 17.5.308-08-00, 6842253 - xs prox body +0.308-15-01, 7037402 - taper locking screw 0.300-21-00, 6248129 - 0mm fixed angled kit.320-42-10, 5874247 - equinoxe reverse 42mm humeral const liner +0.320-10-10, 7045815 - equinoxe reverse tray adapter plate tray +10.
Additional Manufacturer Narrative
Section h10: h3: the incorrect screw implantations reported were likely the result of the sales representative mistakenly opening the incorrect torque screw boxes during each case, which led to implantation of anatomic torque defining screws in reverse humeral trays.Section h11: the following sections have corrected information: b5: it was reported that an atsa torque defining screw was used with a +10mm humeral tray.
Event or Problem Description
It was reported that an atsa torque defining screw was used with a +10mm humeral tray.

• Brand Name: EQUINOX
• Common Device Name: SQUARE TORQUE DEFINE SCREW DRIVE KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14051010
• Report Number: 1038671-2022-00389
• Device Sequence Number: 4621277
• Product Code: KWT
• UDI-Device Identifier: 10885862079473
• UDI-Public: 10885862079473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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 Expiration Date: 08/18/2026
• Device Model Number: 300-20-02
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown