MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPORTMEDS INSTRUMENTS; SCREWDRIVER

Model Number	05.05.10.0120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the cannulated screwdriver shaft t25 broke during acl surgery during mectascrew c introduction into the femoral tunnel.A fragment remained in the patient.The nitinol guide was deformed.Mectascrew c had no damage and has been implanted.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: during the insertion of a mectascrew c interference screw, the tip of the screwdriver broke.The available x-ray image shows one radiopaque speck at the lateral condyle level, which potentially may be interpreted as a metal fragment.This speck could appear within the lodging of the interference screw; however, the single projection makes it challenging to precisely determine its location within the knee.If this speck is indeed a fragment from the instrument, it would be made of medical grade stainless steel not approved for long term implantation.Theoretically, we cannot guarantee that leaving a fragment in situ may not cause secondary problems.However, it is very small and retrieving it would undoubtedly be a very difficult and invasive procedure.Visual inspection performed by r&d project manager: upon reviewing the second complaint, which similarly involved a screwdriver tip breakage, we have identified consistent patterns with the first reported case.An additional dimensional analysis of the screwdriver lot confirmed that the devices conform to specifications.However, based on the evaluation of the device and associated instruments, including the nitinol guidewire used during the procedure, it appears that the guidewire was once again deformed, as described in the event report.While it is not confirmed whether this guidewire is a product of our company, 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, in this case, 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.Batch review performed on 07 october 2024.Lot: 2354341: (b)(4) items manufactured and released on 22-jan-2024.No anomalies found related to the problem.To date, one similar event has been reported on the same lot.

• Brand Name: SPORTMEDS INSTRUMENTS
• Common Device Name: SCREWDRIVER
• 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: 20522209
• Report Number: 3005180920-2024-00855
• Device Sequence Number: 18138447
• Product Code: NBH
• UDI-Device Identifier: 07630971281790
• UDI-Public: 07630971281790
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N/A
• 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

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: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/24/2024
• 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 Age: 23 YR
• Patient Sex: Male