MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM; SPINE ANTERIOR PLATE FLUSH

Model Number	03.30.301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary spine surgery, when the surgeon was adding the alif anti-backout lag plate, the torque limiter handle did not give off a "click" sound to indicate when to stop torsional pressure/force.As a result, the surgeon kept trying to screw in the faceplate and the antibackout screw broke in half.The distal tip of the antibackout screw cold-fused into the faceplate.The surgeon left the 4 primary screws as they were and completed the case without the antibackout plate.The surgeon performed a posterior fixation.
Additional Manufacturer Narrative
Batch review performed on 08-mar-2023.Lot 2220027: (b)(4) items manufactured and released on 21-oct-2022.Expiration date: 2027-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another reported event on the same lot.Other device involved: mectalif 03.30.10.2390 alif lag torque limiter straight handle 2.5nm - hl lot 2254942: (b)(4) items manufactured and released on 08-nov-2022.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Recall is on going.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager (analysis concluded on 03-april-2023).Mectalif 03.30.10.2390 alif lag torque limiter straight handle 2.5nm - hl lot: 2254942.The torque limiter has been inspected and no sign of damage can be found.The device has been tested and found with the correct tolerances of 2.5 nm ± 10%.Ref.03.30.10.2300 alif t15 anti-blackout and offset screwdriver lot: 2254973.Both screwdrivers have been inspected and no sign of damage can be found.The parts are according to the specifications.Ref.03.30.301 mectalif ant - lag plate flush h12 mm lot: 2220027.The fixing screw of the cover plate is broken.Analyzing the breakage surface with a microscope, signs of fracture by torsion can be seen.After internal tests performed on devices of the same batch, the following root cause can be identified: when specific combinations of geometrical conditions meet, the protrusion of the fixing screw inside the lag flush plate is longer than the depth of the female thread, causing the screw to stop advancing during tightening and be consequently stressed under torsion instead of traction.

• Brand Name: MECTALIF ANTERIOR LAG PLATE FLUSH H12 MM
• Common Device Name: SPINE ANTERIOR PLATE FLUSH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16511522
• Report Number: 3005180920-2023-00191
• Device Sequence Number: 6844561
• Product Code: OVD
• UDI-Device Identifier: 07630345732293
• UDI-Public: 07630345732293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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 Model Number: 03.30.301
• Device Catalogue Number: 03.30.301
• Device Lot Number: 2220027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female