MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT; SPINE POLYAXIAL SCREW

Model Number 03.75.004

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2022

Event Type  Injury  

Event Description

During screw insertion on c7 lamina, the screw head hit the bone, and the bone fractured in four points.The trajectory was defined freehand and no tapping was performed (the surgeon used air-tome and then drilled with 03.75.0014; k-wire was not used).Both screws on c7 were removed and replaced.The surgeon changed the trajectory of the screws and used shorter screws to complete the surgery.

Manufacturer Narrative

Batch review performed on 7 october 2022: lot 2021972: (b)(4) items manufactured and released on 24-sep-2020.Expiration date: 2025-sep-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch review performed on 7 october 2022: must mini 03.75.005 must mini polyaxial screw 3.5 x 20 full thread + nut (k171369) lot 1922080: (b)(4) items manufactured and released on 30-sep-2019.Expiration date: 2024-sep-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: during a multi-level posterior cervical spine stabilization surgery, a bone fracture occurs while tightening a pedicle screw.No reason to suspect a faulty device at the origin of this adverse event.

Manufacturer Narrative

Visual inspection performed by r&d manager: based on available information, it was understood that the lamina broke after the insertion of the screw, due to the contact.Bone preparation by using the associated drills and taps is recommended in order to ease the positioning while preventing potential issue that could lead to bone fracture.Additionally, it is not unknown that a deeper positioning of screw in the vertebrae could potential lead to bone failure like fracture, in particular when the bone density quality is not optimal.Visual inspection and a functional check was performed on the retrieved implant for investigation: no evidence of defect or failure was observed.The screw was functional and intact.

• Brand Name: MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT
• Type of Device: SPINE POLYAXIAL SCREW
• 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: 15679054
• MDR Text Key: 302470598
• Report Number: 3005180920-2022-00807
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07630030863189
• UDI-Public: 07630030863189
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171369
• 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,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.75.004
• Device Catalogue Number: 03.75.004
• Device Lot Number: 2021972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian