MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY THREADED PIN Ø3.2 L70 HA3.5 MECHE TRIANGLE; IINSTRUMENT THREADED PIN

Model Number	11.00009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
When the pin was inserted to fix the cutting block it broke at the connection level with the pin adapter.The surgeon used a backup cutting block and pin and the surgery was completed successfully.Delay time 30 minutes.
Additional Manufacturer Narrative
Batch review performed on 09 december 2021.Reference 11.00009 long threaded pins lot 2113716.Lot 2113716: (b)(4) items manufactured and released on 06-oct-2021.Expiration date: 2026-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Threaded pin ø3.2 l70 ha3.5 meche triangle lot.Mat34617: (b)(4) items manufactured and released on 23-jul-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Preliminary investigation: the images of the complaint show the breakage of the triangular motorized connection of the pin.The pin looks bended with signs of damage probably generated when trying to remove the pin stuck in the cutting guide.Also the tip of the pin looks damaged as well as the threaded part.We could imagine that during insertion, the pin was forced against the hole of the cutting guide; the heat generated during the friction could have generated cold welding of the pin on the guide and the consequent breakage of the tip of the pin.More specific information relating to the cause of the complaint can be obtained during the visual inspection.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The visual inspection confirmed the preliminary investigation : " the pin looks bended with signs of damage probably generate when trying to remove the pin stuck in the cut guide.Also the tip of the pin looks damaged as well as the threaded part.We could imagine that during insertion, the pin was forced against the hole of the cutting guide; the heat generated during the friction could have generated cold welding of the pin on the guide and the consequent breakage of the tip of the pin.".No additional information detected during visual inspection.

• Brand Name: GMK EFFICIENCY THREADED PIN Ø3.2 L70 HA3.5 MECHE TRIANGLE
• Common Device Name: IINSTRUMENT THREADED PIN
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12982546
• Report Number: 3005180920-2021-00971
• Device Sequence Number: 14598593
• Product Code: LXH
• UDI-Device Identifier: 07630030842740
• UDI-Public: 07630030842740
• 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): 02/15/2022

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 Expiration Date: 09/15/2026
• Device Model Number: 11.00009
• Device Catalogue Number: 11.00009
• Device Lot Number: 2113716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian