MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN; SPINE PEDICLE SCREW

Model Number 03.57.024

Device Problem Failure to Advance (2524)

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

Event Date 10/04/2021

Event Type  malfunction  

Event Description

The surgeon couldn`t insert the pedicle screw into the patient`s bone despite he performed tapping.The same problem occurred with two other screws of the same size.Finally, he used 7mm screw and the surgery was completed successfully with 1 hour of delay and a total surgery time of 3.5h.The surgery was l4/l5 fusion.This event occurred during inserting l5 screw.

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 14 october 2021: lot 2024304: (b)(4).Expiration date: 2026-03-23.No anomalies found related to the problem.(b)(4).Additional devices involved: batch review performed by medacta regulatory affairs department on 14 october 2021: must lt 03.57.024 must lt 15mm short - pedicle screw ø6x40 cann (k203482) lot 2122304: (b)(4).Expiration date: 2026-04-19.No anomalies found related to the problem.(b)(4).Visual inspection performed on 19 october 2021 by medacta r&d spine manager: the surgeon couldn`t insert the pedicle screw into the patient`s bone despite he performed tapping.Internally we tested the implants present in our warehouse with the same lot number of the implant involved and, we tested the same semi-finished screws (same batch number) of the implant involved trying to insert them on the sawbones following the same surgical procedure using the tap and without using the tap.The results obtained are positive, all the screws are screwed without any sort of problem.The same test has been performed with the implants received and the results are the same.No issue detected during insertion.With the information received and according to the results obtained with the internal tests is not possible to describe a route cause of the complaint.

• Brand Name: MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN
• Type of Device: SPINE PEDICLE 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: 12743398
• MDR Text Key: 284476077
• Report Number: 3005180920-2021-00844
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971278387
• UDI-Public: 07630971278387
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.57.024
• Device Catalogue Number: 03.57.024
• Device Lot Number: 2024304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2020
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian