MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MC SCREW Ø6X35 CANNULATED; SPINE PEDICLE SCREW

Catalog Number	03.58.243
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient match planning review performed by mysolution department: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We are going to reproduce both l04 and l05 guides (with their bone model) in order to check the fitting again.Additional implants involved, batch review performed on 08-sep-2023: pedicle screw 03.56.504 must mc cross-connector 27-40mm adjustable (k193365) lot 2124275: (b)(4) items manufactured and released on 16-sep-2021.Expiration date: 2026-08-23.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported case during the period of the review.Pedicle screw 03.58.243 must mc screw ø6x35 cannulated (k210427) lot 2229874: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2028-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The surgery was conducted on l4-l5 tlif.The screw was inserted by using a guide pin after the preparation of screw trajectory by using myspine mc drill-based guide l04.It has been observed that the screw trajectory deviated greatly from the planned one and a different trajectory was made by freehand.A new screw (same reference and lot) was implanted.It was not possible to implant the must mc cross-connector 27-40mm adjustable because it was beyond the connector angular range.The patient bone quality was hard.The surgery was completed successfully.Delay time was 30min.
Event or Problem Description
The surgery was conducted on l4-l5 tlif.The screw was inserted by using a competitor guide pin (ø 1.5mm) after the preparation of screw trajectory by using myspine mc drill-based guide l04.It has been observed that the screw trajectory deviated medially from the planned one and a different trajectory was made by freehand.It has been reported that the drilled left l04 trajectory was fine and it was not deviated before the guide pin insertion.Moreover, the l04 entry point has been prepared according to the skiving warning on the planning.Issue detected only at l04 level.A new screw (same reference and lot) was implanted.It was not possible to implant the must mc cross-connector 27-40mm adjustable because it was beyond the connector angular range.The patient bone quality was hard.The surgery was completed successfully.Delay time was 30min and total time of the surgery was 3h.
Additional Manufacturer Narrative
The pedicle screw and the cross connector returned on 13-sep-2023.03.58.243 must mc screw ø6x35 cannulated lot.2229874.03.56.504 must mc cross-connector 27-40mm adjustable lot.2124275.Visual inspection performed by r&d project manager no issues can be identified on the implants.No root cause can be identified for the event detected.Match planning review performed by mysolution department our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We reprinted the guides in order to check the fitting again and the result is conform; the guides have a stable position without any defect.Batch review performed on 16-oct-2023 myspine 7.0724 myspine mc drill-based guide l04 lot.10506s lot 10506s: (b)(4) items manufactured and released on 25-jul-2023.Expiration date: 2024-01-11.No anomalies found related to the problem.The complaint additional information received were reported in the event description.

• Brand Name: MUST MC SCREW Ø6X35 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: 17710244
• Report Number: 3005180920-2023-00700
• Device Sequence Number: 2235922
• Product Code: NKB
• UDI-Device Identifier: 07630971293557
• UDI-Public: 07630971293557
• 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): 11/10/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.58.243
• Device Lot Number: 2229874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian