MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW LENKE PROBE SQUARE TIP - CURVED; SPINE SURGICAL INSTRUMENT

Catalog Number	03.51.10.0601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery (l3-s1), the curved probe broke, while preparing the first screw bone.The broken part was recovered by the bone and the surgery was completed successfully.The pedicle screw was 6mm ø x 50mm length.The patient bone was very dense.The surgeon took 20 minutes (total surgery time 2h and 20 minutes) to retrieve the fragment that was in the pedicle, he used a burr and a rongeur and retrieved the fragment and then used 45 and 50 taps.
Additional Manufacturer Narrative
Batch review performed on 25 march 2024 lot 2056183: (b)(4) items manufactured and released on 23-apr-2021.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.Visual inspection performed by r&d project manager.According to picture and device received, during the surgery the tip of the lenke probe broke.The root cause of the failure might be the application of a bending force while the instrument's tip was inserted in the patient's bone.

• Brand Name: PEDICLE SCREW LENKE PROBE SQUARE TIP - CURVED
• Common Device Name: SPINE SURGICAL 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: 19086151
• Report Number: 3005180920-2024-00224
• Device Sequence Number: 15229477
• Product Code: LXH
• UDI-Device Identifier: 07630971266803
• UDI-Public: 07630971266803
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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: 03.51.10.0601
• Device Lot Number: 2056183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: Male
• Patient Race: White