MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 02.07.10.1040 PUNCHER SIZE 3/4; INSTRUMENT FOR KNEE SURGERY

Model Number	02.07.10.1040
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by medacta knee r&d project manager: the possible reasons for the fracture are: sclerotic bone, high force applied during impaction, keel puncher worn out, not complete keel preparation.
Event or Problem Description
During the tibial preparation in the primary knee surgery, the surgeon cracked the tibia with the tibial puncher.The surgeon used cables around the tibia to prevent the propagation of the fracture.There was a 5-minutes delay in the surgery and the surgery was completed successfully.A loaner set was utilized.

• Brand Name: GMK 02.07.10.1040 PUNCHER SIZE 3/4
• Common Device Name: INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10654568
• Report Number: 3005180920-2020-00692
• Device Sequence Number: 17032191
• Product Code: LXH
• UDI-Device Identifier: 07630040758154
• UDI-Public: 07630040758154
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 10/09/2020

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: 02.07.10.1040
• Device Catalogue Number: 02.07.10.1040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention