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

Catalog Number	05.05.10.0120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 june 2024.Lot 2354341: (b)(4) items manufactured and released on 22-jan-2024.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 based on the analysis of the complaint device and pictures of the associated instruments (i.E., nitinol guidewire) used during the procedure, it appears that the nitinol guidewire used to guide the screwdriver was bent.A possible root cause of the wire bending could be due to unintentional incorrect insertion orientation of the wire relative to the existing bone tunnel, causing the wire to become "stuck" within the bone or the graft in the created bone tunnel.As a result, due to the inadequate direction of the guidewire, the screwdriver, coupled with the mectascrew c, may have collided with the nitinol shaft during insertion, introducing extra forces on the screwdriver tip, and as a result causing its breakage.Therefore the device's failure root cause, in this case, could be associated with a minor surgical technique execution discrepancy.Clinical evaluation performed by medical affairs director 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.Additionally, a second, less radiopaque speck, is visible more proximally but its nature is difficult to ascertain.The single projection makes it challenging to precisely determine their locations within the knee.If these specks are indeed fragments of the instrument, they would be made of medical grade stainless steel not approved for long term implantation.Therefore, we cannot guarantee that leaving fragment(s) in situ may not cause secondary problems.However, retrieving such small fragment(s) would undoubtedly be a very difficult and invasive procedure, so the surgeon decided to avoid it.Note: the incident occurred on may 28th, 2024 and medacta became aware of the event on the same day.Initially, it was hypothesized that the small signs visible from the x-rays were fragments originating from the screw, which is composed of resorbable material.During the preparation of the final report on aug 26th, 2024, an overview of all the analyses and investigations carried out on the case was conducted.It was precisely at this stage that the clinical analysis provided crucial insights, revealing that the fragments could potentially be metal fragments originating from the broken instrument, although it cannot be confirmed.Consequently, given the implications of these findings, the risk assessment was carefully reconsidered and adjusted, leading to the decision to report the case.
Event or Problem Description
The tip of the cannulated screwdriver shaft t25 and the mectascrew c broke, probably due to malpositioning of the nitinol wire.The graft was undamaged and the surgeon used a new screw and another screwdriver to successfully complete the surgery.

• Brand Name: SINGLE BUNDLE ACL CANNULATED SCREWDRIVER SHAFT T25
• 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: 20118027
• Report Number: 3005180920-2024-00736
• Device Sequence Number: 3226437
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2024

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: 05.05.10.0120
• Device Lot Number: 2354341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/02/2024
• 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: 85 YR
• Patient Sex: Male
• Patient Race: White