MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE TORQUE DEFINING SCREW KIT

Catalog Number 320-20-00

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): humeral adapter tray (cat#: 320-10-00 / sn#: (b)(4).42mm humeral liner (cat#: 320-42-00 / sn#: (b)(4).

Event Description

As reported, the initial implant of the (b)(6) male patient's left shoulder was (b)(6) 2019.The patient complained of "clicking" sound in his left shoulder to surgeon some time after surgery.After x-raying the shoulder the surgeon discovered that the humeral platform tray had separated from the humeral stem with humeral liner still attached to the tray.The patient was then scheduled for a left shoulder revision on (b)(6) 2020.The surgeon revised the patient's shoulder by replacing the humeral tray, torque screw, and humeral liner.Upon initial inspection of failed implants there did not appear to be any obvious signs of failure.Possible worn down/stripped threads on the end of the torque screw.Replaced torque screw and humeral tray had no issues implanting and fixating into the humeral stem.Patient was last known to be in stable condition following the event.Product will be returned for evaluation.

Manufacturer Narrative

(h3) the revision surgery reported in was most likely the result of the humeral adaptor tray not being fully seated on the humeral stem at the time of implantation and/or cross-threading of the equinoxe reverse torque defining screw with the humeral stem.Consequently, the torque defining screw likely did not fully engage with the internal threads on the humeral stem, allowing the torque defining screw to back out and result in the reported disassociation of the humeral adaptor tray from the humeral stem.Section h11: *the following sections have corrected information: (e2) health professional?: yes.

• Brand Name: EQUINOXE
• Type of Device: REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9687443
• MDR Text Key: 186832178
• Report Number: 1038671-2020-00036
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR