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, while the surgeon was tightening the anti back out lag cover plate, the surgeon thought he had locked the plate.The surgeon then removed the plate holder along with the driver and the surgeon then noticed that the antibackout cover plate was still attached to the plate holder.The surgeon also observed that the top of the screw had broken off from the threaded portion.The surgeon left the threaded portion of the screw in the plate and continued with the case.No posterior fixation performed.
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.Note: recall is on going.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager ref.(b)(4) 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 and comparing it with the fracture surface of a tested screw 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.Modification of the implants will be made under mr 038-23, to prevent the occurrence of this issue.

• 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: 16511523
• Report Number: 3005180920-2023-00193
• Device Sequence Number: 6844562
• 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): 03/09/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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: Unknown