MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-20-26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgical use, the compression screw broke while the surgeon was implanting.The broken portion remains in the patient.No adverse effects.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 300-30-07, equinoxe preserve stem 7mm, 6960881, 315-35-00, glnd kwire, 6893917, 320-10-00, equinoxe reverse tray adapter plate tray +0 a130292, 320-15-05, eq rev locking screw, a140142, 320-20-00, eq reverse torque defining screw kit, a122563, 320-20-22, eq rev compress screw lck cap kit, 4.5 x 22mm, a085612, 320-20-30, eq rev compress screw lck cap kit, 4.5 x 30mm, a143906, 320-20-34, eq rev compress screw lck cap kit, 4.5 x 34mm, a121955, a140900, 320-31-40, glenosphere, 40mm 7007760, 320-35-01, small glenoid plate a088033, 320-40-03, humeral liner, 40mm, +2.5 6168382, 531-78-20, shouldr gps hex pins kit, a116186.
Additional Manufacturer Narrative
H3: the fracture of the compression screw during implantation reported in (b)(4) was most likely the result of applying torque greater than the yield strength of the material, possibly secondary to contributions from hard bone or seating the screw under power.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The complaint event was reassessed to be not reportable: upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15550168
• Report Number: 1038671-2022-01264
• Device Sequence Number: 6158081
• Product Code: KWT
• UDI-Device Identifier: 10885862086549
• UDI-Public: 10885862086549
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2025
• Device Model Number: 320-20-26
• Device Catalogue Number: 320-20-26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 03/03/2026
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/05/2022; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female