MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPORTMEDS INSTRUMENTS; SINGLE BUNDLE ACL CANNULATED SCREWDRIVER SHAFT T25

Model Number	05.05.10.0120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 october 2024 lot 2354341: (b)(4) items manufactured and released on 22-jan-2024.No anomalies found related to the problem.To date, two similar events have been reported on the same lot.Clinical evaluation performed by medical affair director during a surgical procedure, the tip of the cannulated screwdriver broke, as clearly shown in the available images.No information has been provided regarding the retrieval of the metallic fragment, but based on the available x-ray, no radiopaque fragments referable to this can be identified.Therefore, we do not anticipate any secondary issues for the patient related to this event.Visual inspection performed by r&d project manager based on the information received, the guidewire used in combination with the screwdriver was not manufactured by medacta and it was deformed, as described in the event report.Additionally to the outcomes unpredictability due to different manufacturer instruments combination, a possible root cause of the bending could be the unintentional misalignment of the guidewire relative to the existing bone tunnel.This misalignment might have caused the guidewire to become "stuck" within the bone or graft.Due to the inadequate alignment, the screwdriver, along with the mectascrew c, may have come into contact with the bent guidewire during insertion, applying additional forces to the screwdriver tip and potentially causing its breakage.Therefore, the root cause of the device failure may be linked to a minor deviation in surgical technique, particularly in the placement or alignment of the guidewire relative to the bone tunnel and the usage in combination with not foreseen competitors instruments.The root cause is likely a sub-optimal orientation of the guidewire during insertion, which led to a collision between the guidewire and the screw-screwdriver assembly, introducing additional forces on the screwdriver tip and consequently causing its breakage.
Event or Problem Description
The tip of the cannulated screwdriver shaft t25 broke because the nitinol was bent.No pieces left in the patient.The screwdriver has been used in combination with a competitor's nitinol wire.

• Brand Name: SPORTMEDS INSTRUMENTS
• Common Device Name: SINGLE BUNDLE ACL CANNULATED SCREWDRIVER SHAFT T25
• 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: 20693613
• Report Number: 3005180920-2024-00937
• Device Sequence Number: 17941280
• Product Code: NBH
• UDI-Device Identifier: 07630971281790
• UDI-Public: 07630971281790
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 11/15/2024

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 Model Number: 05.05.10.0120
• Device Lot Number: 2354341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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: Male