MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; MOTO PARTIAL KNEE 02.07.10.2294 PIN Ø3.2 L=40 MM HA3.5 MECHE HEAD TRIANGLE

Model Number	02.07.10.2294
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 4 april 2025 lot 1750645: (b)(4) items manufactured and released on 04-sep-2017.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.R&d investigation the pin is broken at the end of the threaded part.The pin appears completely worn with signs of damage in the whole length.Also, the thread is totally flattened.The pin involved in the complaint has been compared with a new device of the same reference: the wear on both the threaded part and smooth area due to prolonged use is clearly evident.We could assume that the pin was damaged during previous surgeries and, due to the reduced performance of the worn thread, the pin could be overheated during the last insertion into the cutting guide up to the final breakage.Clinical evaluation during partial knee replacement performed by an expert surgeon, a pin broke during removal.Due to the position of the fragment, it was necessary to prolong the surgery and make an additional small posterior access to remove it.Except for the prolonged surgery time, no other adverse consequence was experienced or is to be expected.It appears that progressive damage over the useful life of the device resulted in the issue reported, while no systemic deficiency can be identified based on this case and the investigation results do not indicate any potential manufacturing issue.
Event or Problem Description
The pin broke while taking it out from the 2-in-1 cutting guide.The broken part remained stuck in the bone.Bone quality was very good.When the surgery was completed, the patient was turned into a prone position to remove the pin part from posterior approach.No additional anesthesia was administered, but the surgery was prolonged by about 40 minutes, and the total surgery time was approximately 2 hours.The surgeon reported that it is possible the pin was already worn before use, since the set has been with the hospital for quite some time.A further indication of the prior wear might be that there was no lot number readable on the pins anymore.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: MOTO PARTIAL KNEE 02.07.10.2294 PIN Ø3.2 L=40 MM HA3.5 MECHE HEAD TRIANGLE
• 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: 21890741
• Report Number: 3005180920-2025-00305
• Device Sequence Number: 17026691
• Product Code: LXH
• UDI-Device Identifier: 07630040763189
• UDI-Public: 07630040763189
• 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): 04/23/2025

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: 02.07.10.2294
• Device Lot Number: 1750645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 54 YR
• Patient Sex: Male