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
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00807
• Device Sequence Number: 15447461
• Product Code: NKG
• UDI-Device Identifier: 07630030863189
• UDI-Public: 07630030863189
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian