MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5.5X35 (DOUBLE PACKAGING)

Catalog Number 03.30.126

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs on 21 february 2018: intraoperative fracture of a cervical screw.There are no elements to determine a clinical cause to this fracture.No clinical consequence should be expected, although the images supplied do not allow to judge the final screw position, which however has been deemed satisfactory by the surgeon.Mechanical considerations are beyond the scope of the clinical investigation.Batch review performed on 22 february 2018; lot 140630: (b)(4) items manufactured and released on 02 july 2014.Expiration date: 2019-05-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by the r&d project manager on 22 february 2018 on the screw head received: the breakage of the screw, reference 03.30.126, lot 140630, occurred at 5mm from the top of the head.It's a brittle breakage due the application of a high torsion-bending load.According to previous tests performed by an external laboratory, the maximum torque to failure of the screw is above 9.8 nm in the plate and above 7.4 nm while not in the plate.As described in the report, the breakage occurred during the attempt to remove and reposition the caudal-lateral screw.Due to the fact that the screw was completely inserted into the vertebral body during a preliminary step, we can infer that the removal torque is lower than the one needed for the insertion.The type of breakage seems more compatible with the attempt to reposition the screw inside the plate or a torsion-bending load applied on the screw.In fact, as the alif screw has a mechanical engagement with the plate, via an internal female thread, only a specific angulation of the screw can be achieved after assembly.If the attempt to reposition the screw resulted in an unintended or unperceived application of a torsion-bending load it could have caused the breakage of the screw.

Event Description

When the last screw was put in place, an image was taken and the surgeon was not fully satisfied with the position of that screw.When attempting to reverse and reposition the screw, the head of the screw broke.The surgeon did not over-angle the screwdriver and there were no incorrect procedural steps in the operation.Everything was perfectly fine and well done.There was no danger for the patient and the rest of the screw had good fixation, so the remaining portion of the screw was left in place.The involved screw was not implanted with the torque limiter.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5.5X35 (DOUBLE PACKAGING)
• Type of Device: ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7344702
• MDR Text Key: 102595723
• Report Number: 3005180920-2018-00150
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030833540
• UDI-Public: 07630030833540
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 03.30.126
• Device Lot Number: 140630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 75