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

Model Number 300-20-02

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 03/09/2022

Event Type  Injury  

Event 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).

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.

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 Description

It was reported that an atsa torque defining screw was used with a +10mm humeral tray.

• Brand Name: EQUINOX
• Type of Device: 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
• MDR Text Key: 288852596
• Report Number: 1038671-2022-00389
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079473
• UDI-Public: 10885862079473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention