MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC SCREW Ø6X40 CANNULATED; SPINE PEDICLE SCREW

Catalog Number	03.58.244
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03 april 2024: lot 2328485: (b)(4) items manufactured and released on 13-nov-2023.Expiration date: 2028-11-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Investigation performed by medacta spine r&d project manager: according to pictures received and event description, the setscrew broke in corresponence to one of the lobes of torx t27 interface, during final tightening operation using countertorque and setscrewdriver connected to torque limiter.With data available at the moment, a certain root cause cannot be identified.Given the extremely low occurrence rate of this kind of issue, it is very unlikely that the event has been caused by a systematic defect in the batch of the setscrew.
Event or Problem Description
The set screw of must mc screw ø6x40 cannulated cracked during final tightening.The set screw could not be disengaged, so the surgeon cut and removed the rod, revised the pedicle screw and engaged a new rod.There was 20 min of delay (total surgery time 3 hours).
Additional Manufacturer Narrative
Visual inspection performed on 22 april 2024 by medacta r&d spine project manager: the setscrew is aligned to the tulip, twisting of one portion iccurred after the breakage of the implant.Setscrew lot 2324706: no issues are related to the batch so far.Metallografic analysis confirmed that the material is according to specification.Root cause for the breakage may be lateral bending due to a suboptimal alignment of the screwdriver during final tightening.Correction: b.2 is other serious or important medical events and not required intervention to prevent permanent impairment/damage.

• Brand Name: PEDICLE SCREW MUST MC SCREW Ø6X40 CANNULATED
• Common Device Name: SPINE PEDICLE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19049140
• Report Number: 3005180920-2024-00207
• Device Sequence Number: 17947895
• Product Code: NKB
• UDI-Device Identifier: 07630971293564
• UDI-Public: 07630971293564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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 Catalogue Number: 03.58.244
• Device Lot Number: 2328485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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: Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian