MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD; CAGE'S SCREW

Catalog Number 03.30.156

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28 november 2019.Lot 1922393: (b)(4) items manufactured and released on 05-sep-2019.Expiration date: 2024-07-27.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.Preliminary investigation performed by r&d project manager from the picture attached in the complaint and by the description of the event, it's possible to see that the head is broken.This event occurred during the tightening of the screw into the vertebral body.The total length of the broken piece is approximately 7-8mm, this means that in the bone and plate there are fixed 22-23mm of the screw.It's not clear from the event description which instruments have been used for the screw hole preparation: awl, drill, tap etc.Neither which instruments have been used for the screw insertion.In addition, it could be helpful to know in which level (i.E.L5) and in which direction (cranial/caudal) the surgeon was tightening the screw.Despite of the missing information that it's possible to collect before the visual inspection, it's possible to expect that the root cause of the event is the application of a huge or uncontrolled torsion on the screw, above 7nm (see report 167_120807_120_297-rev0).As additional information, for the fixation of the screw, it has to be applied a torsion of 5nm (+/-10%) with a specific torque limiter available in the set.Despite the missing piece of the screw, the fixing mechanism is not compromised.In fact, the plate is threaded and there is no risk of screw migration.Preliminary investigation performed on (b)(6) 2019.

Event Description

During the primary spine surgery, while the surgeon was inserting screws and driving the screw down with the driver, the screw broke.The surgeon was able to remove the head of the screw, however, the other half is stuck in the patient's bone.There was a 10-minute delay and the surgery was completed successfully.

• Brand Name: MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
• Type of Device: CAGE'S 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9479948
• MDR Text Key: 173902848
• Report Number: 3005180920-2019-01050
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630040727969
• UDI-Public: 07630040727969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.30.156
• Device Lot Number: 1922393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2019
• 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