MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; MUST POLYAXIAL CANN SCREW Ø6X35 - Ø5.5/6

Model Number	03.68.380
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon could not tighten the set screws (usingthe final tightener from must 2.0) onto the tulip of two 6.0x35mm screws, as the thread kept stripping.No different setscrew was used before removing the pedicle screws.The pedicle screws were explanted, and 6.0x40mm pedicle screws were inserted.There was a 30-minute delay.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-dec-2025.Must lt 03.68.380 must polyaxial cann screw d 6x35 - d 5.5/6 (k234048) lot.2329179: (b)(4) items manufactured and released on 20-feb-2024.Expiration date: 2029-02-04.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.Must lt 03.68.380 must polyaxial cann screw d 6x35 - d 5.5/6 (k234048) lot.2464191: (b)(4) items manufactured and released on 19-nov-2024.Expiration date: 2029-11-04.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.Root cause:although it is not possible to confirm, the damage of the threads likely involved a suboptimal alignment of the components during the first attempt at engagement.The investigation does not indicate any potential manufacturing-related issue or systemic deficiency.
Additional Manufacturer Narrative
On 20-jan-2026 we were informed that the devices involved in this event were not available for inspection.Differently from what was initally comunicated.Field d9 has been updated accordingly.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: MUST POLYAXIAL CANN SCREW Ø6X35 - Ø5.5/6
• 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: 24051153
• Report Number: 3005180920-2026-00010
• Device Sequence Number: 9855842
• Product Code: NKB
• UDI-Device Identifier: 07630542704482
• UDI-Public: 07630542704482
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K234048
• 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): 01/20/2026

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 Model Number: 03.68.380
• Device Lot Number: 2329179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Black Or African American