MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE INSTRUMENTS; PEDICLE SCREW LENKE PROBE - SQUARE TIP - STRAIGHT

Model Number	03.51.10.0600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03-mar-2025: lot: 1956787: (b)(4) items manufactured and released on 28-07-2020.No anomalies found related to the problem.To date 2 other similar events have been reported.Preliminary investigation performed by medacta spine r&d project manager: according to picture 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.Although the specific circumstances cannot be confirmed, the issue may have resulted from unique conditions of the specific surgical application involved in combination with the inherent mechanical limits of the device version utilized.The investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
During l1-s2-si surgery, the surgeon malleted the leke probe in right l2 and the tip of the device broke in the pedicle.A trephine along with a pair of vice grips was utilized to remove the broken tip.Bone quality was reported not being sclerotic but issue in advancing the gear shift that required malleting.Surgery was completed successfully with 30 minutes of delay on 4 hours of surgery.7.0mm (diameter) x55mm (length) screw was implanted.
Additional Manufacturer Narrative
Visual inspection performed by r&d department inspection of the returned devices confirmed preliminary inspection analysis.Preliminary investigation performed by r&d department (already reported in the mdr 2025-00207): according to picture 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.Although the specific circumstances cannot be confirmed, the issue may have resulted from unique conditions of the specific surgical application involved in combination with the inherent mechanical limits of the device version utilized.The investigation does not indicate any potential manufacturing related issue.

• Brand Name: SPINE INSTRUMENTS
• Common Device Name: PEDICLE SCREW LENKE PROBE - SQUARE TIP - STRAIGHT
• 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: 21718316
• Report Number: 3005180920-2025-00207
• Device Sequence Number: 21216636
• Product Code: LXH
• UDI-Device Identifier: 07630971266797
• UDI-Public: 07630971266797
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 03.51.10.0600
• Device Lot Number: 1956787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American