MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; THREADED PIN Ø3.2 L85 LONGER CONNECTION

Model Number	02.07.10.4741
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 jun 2025.(b)(4) items manufactured and released on 04-apr-2023.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Clinical evaluation performed by clinical affairs director.During primary tka surgery, a drill bit breaks inside the bone and needs retrieval through a small opening in the bone.The consequences of this event are most likely negligible; probably they can be reduced to a legthening of the surgery time.The causes cannot be determined with certainty, it is likely that some excessive bending stress was applied, unless the instrument was already damaged at surgery start.
Event or Problem Description
The surgeon found that the tip of drill pin was fractured after removing the pin from myknee femoral cutting block.The surgeon confirmed from the fluoroscopy images that the broken pin tip remained inside the bone.A small opening was made in the femur, and the pin fragment was removed.The surgery was completed successfully.Total surgery time was 2.5 hours, the delay time was 30-40 minutes.
Additional Manufacturer Narrative
Visual inspection performed by r&d department.The visual inspection confirmed the breakage of the tip of the pin.Signs of damage/wear are clearly visible on the external surface of the pin: since the pin was used in combination with efficiency plastic guides, probably the damage is attributable to previous uses with metal guides.The spiral signs of damage are compatible with the friction of the pin against a metal body.We may suppose that the pin was already damaged before the surgery and probably wasn't in perfect condition to be used during a new surgery.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: THREADED PIN Ø3.2 L85 LONGER CONNECTION
• 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: 22289252
• Report Number: 3005180920-2025-00548
• Device Sequence Number: 12980649
• Product Code: LXH
• UDI-Device Identifier: 07630040790840
• UDI-Public: 07630040790840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.07.10.4741
• Device Lot Number: 2255979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 62 YR
• Patient Sex: Female