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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2023-00025
• Device Sequence Number: 20247684
• Product Code: KWT
• UDI-Device Identifier: 10885862086594
• UDI-Public: 10885862086594
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 05/17/2023; 05/05/2026
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2019
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male