MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-20-46

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: pending evaluation concomitant medical products: serial #: (b)(4), catalog: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, serial #: (b)(4), catalog: 315-35-00 - glnd kwire, serial #: (b)(4), catalog: 320-40-03 - 145-deg pe 40mm hum liner +2.5, serial #: (b)(4), catalog: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, serial #: (b)(4), catalog: 320-35-03 - small posterior augment glenoid plate, left, serial #: (b)(4), catalog: 320-10-00 - equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), catalog: 300-30-06 - equinoxe preserve stem 6mm, serial #: (b)(4), catalog: 319-01-32 - steinmann pin sterile 3.2mm x 178mm, serial #: (b)(4), catalog: 320-15-05 - eq rev locking screw, serial #: (b)(4), catalog: 521-78-31 - threaded pin size 2.6 collarless 2pk, serial #: (b)(4), catalog: 320-20-00 - eq reverse torque defining screw kit, serial #: (b)(4), catalog: 321-52-07 - 3.2mm drill bit sterile, serial #: (b)(4), catalog: 320-31-40 - glenosphere, 40mm, serial #: (b)(4), catalog: 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, serial #: (b)(4), catalog: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, serial #: (b)(4), catalog: 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.

Event Description

It was reported that during insertion of the screw, the head of the screw sheared off from the body.The body of the screw stayed in the patient's glenoid, but no other pieces stayed in.This 63 y/o, male patient was last known to be in stable condition following the event.No other patient information/medical history reported.Device is not returning.

Manufacturer Narrative

(h3) the fractured screw reported was likely the result of applying torque greater than the yield strength of the material during implantation.However, this cannot be confirmed because the component was not available for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 568, screw.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16112328
• MDR Text Key: 306799143
• Report Number: 1038671-2023-00025
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086594
• UDI-Public: 10885862086594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 320-20-46
• Device Catalogue Number: 320-20-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2019
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male