MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION DEVICE SHORT; INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0490
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by spine r&d project manager: for both instruments, one of the pins that grab the pedicle screw head is broken and missing.In addition, several scratches and deformation can be seen on the tips of the arms.A certain root cause cannot be clearly identified, however potential reasons may be: excessive reduction force applied to the instruments; sub-optimal screw head engaging, that led the reduction force to be supported only by 2 teeth instead of 4, stressing the component beyond its mechanical limit; incomplete unfastening of the instrument's threaded shaft prior to engaging and/or disengaging the pedicle screw head: the device features a safety mechanism that, if the threaded shaft is not completely unfastened, prevents the opening of the two arms.If the instrument is forced by means of flexional and/or torsional manoeuvres to grab or to release the pedicle screw head, stress on the pins and consequent failure may occurr.Batch review performed on 24-apr-2024: lot 2156589: (b)(4) items manufactured and released on 27-jan-2022.No anomalies found related to the problem.To date, 5 other similar events have been reported on the same lot during the period of review (all the instruments are involved in this complaint).
Event or Problem Description
During a spine surgery performed for scoliosis correction, one of the teeth of six reduction devices broke while executing the correction.The surgery was anyway completed successfully using back up instruments and no delay has been reported.Total time of the surgery was approximately 2 hours and 30 minutes.

• Brand Name: PEDICLE SCREW REDUCTION DEVICE SHORT
• Common Device Name: INSTRUMENT FOR SPINE SURGERY
• 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: 19211478
• Report Number: 3005180920-2024-00284
• Device Sequence Number: 18191342
• Product Code: LXH
• UDI-Device Identifier: 07630971251304
• UDI-Public: 07630971251304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: 03.51.10.0490
• Device Lot Number: 2156589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female