MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT SCREWDRIVER - INNER SHAFT 15MM THREAD; SPINE SCREWDRIVER

Model Number 03.52.10.0723

Device Problems Defective Component (2292); Separation Failure (2547)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 12 october 2021: lot 2054556a: (b)(4) items manufactured and released on 16-feb-2021.No anomalies found related to the problem.To date, no other similar events have been reported.Another instrument involved: batch review performed on 12 october 2021: must lt 03.52.10.0709 quick screw driver - long or short lot.2054547: (b)(4) items manufactured and released on 04-mar-2021.No anomalies were found related to the problem.To date, no other similar events have been reported.

Event Description

During the primary spine surgery, the surgeon was not able to load the must lt screw to the modular screwdriver.It was unclear if the modular screwdriver was broken or assembled incorrectly.The surgeon used instead the quick screwdriver and loaded correctly the must lt screw.After inserting the quick screwdriver (with the attached must lt screw), the surgeon was not able to remove the screwdriver from the screw.The surgery was completed successfully using a competitor screw system with 30 minutes of delay in the surgery.

Manufacturer Narrative

On november 05th we received the items involved in the event.Visual inspection performed by r&d project manager: the surgeon was not able to couple the implant with the polyaxial screwdriver.The surgeon had to abandon using the modular screwdriver and opted to use the quick screwdriver.The surgeon was able to load the must lt screw onto the quick screwdriver.However, after inserting the quick screwdriver the surgeon was not able to remove the screwdriver from the screw.The parts involved in the complaint have been checked and tested with positive results detecting any sort of not conformity.

• Brand Name: MUST LT SCREWDRIVER - INNER SHAFT 15MM THREAD
• Type of Device: SPINE SCREWDRIVER
• 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: 12719411
• MDR Text Key: 280936687
• Report Number: 3005180920-2021-00839
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630345704320
• UDI-Public: 07630345704320
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.52.10.0723
• Device Catalogue Number: 03.52.10.0723
• Device Lot Number: 2054556A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other