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

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	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a spine surgery performed for scoliosis correction, one of the teeth of two reduction devices broke while executing the correction.These metal fragments from both the instruments remained in the patient and are visible from the x-rays.The surgery was anyway completed successfully using back up instruments and no delay has been reported.Total time of the surgery was approximately 3 hours.
Additional Manufacturer Narrative
Batch review performed on 12-apr-2024: lot 2156589: 111 items manufactured and released on 27-jan-2022.No anomalies found related to the problem.To date, another similar event has been reported on the same lot during the period of review.In this other complaint 6 devices are involved in the case.Visual inspection performed by 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.Clinical evaluation performed by medical affairs department: during a scoliosis correction surgery, two short reduction device experienced the breakage of their metallic teeth.Subsequent x-rays revealed two small metal fragment in the back of the patient.Due to thier minuscule size, identifying and removing them probabily proved challenging during the surgery.Even though the material of the instruments is medical grade stainless steel they do not belong to the series approved for long term implantation and therefore we cannot forsee the long term consequences.However, retrieving the fragments would necessitate a very invasive procedure due to their small size and therefore the surgeon has decided to leave them in place.Additional device involved, batch review performed on 12-apr-2024: pedicle screw 03.51.10.0490 reduction device short lot 2253211: 46 items manufactured and released on 05-aug-2022.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.

• Brand Name: PEDICLE SCREW REDUCTION DEVICE SHORT
• Common Device Name: SPINE INSTRUMENT
• 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: 19228465
• Report Number: 3005180920-2024-00285
• Device Sequence Number: 17825744
• 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): 05/02/2024

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: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown