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

Device Problem Break (1069)

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

Event Date 09/16/2022

Event Type  Injury  

Event 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.

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.

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.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15550168
• MDR Text Key: 301926258
• Report Number: 1038671-2022-01264
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086549
• UDI-Public: 10885862086549
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Female