MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE TIBIAL CUTTING BLOCK - SIZE 4

Catalog Number	4.1084
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 13 october 2017 the patient match department provided a planning review reporting as follows: the problem reported by the surgeon was due to a wrong tibia cutting block's position on the bone model.The position chosen by the designer brought to an interference with the tibia tuberosity and a reduced space for the patellar tendon.This was not compliant with the standard in force, which clearly specifies that "move the main part of the mytibia cutting guide in order to avoid any contact with the tibia tuberosity.The distance has to be 14-15 mm.Moreover, avoid the positioning of the anterior pad on the tuberosity (if it is necessary, perform a cut on this pad)." conclusions: the problem reported by the surgeon was due to a wrong tibia cutting block's position on the bone model.The position chosen by the designer brought to an interference with the tibia tuberosity and a reduced space for the patellar tendon.All the operators involved in these activities were successfully trained.This is an isolated human error.Batch review performed on 30 october 2017.Lot 56213k: (b)(4) items manufactured and released on 15 september 2017.Expiration date: 2018-03-16.No anomalies found related to the problem.To date, no other events have been on items of the same lot.
Event or Problem Description
The myknee tibial cutting block was not used due to impingement with the patellar tendon.The surgery was completed successfully using the conventional system.
Additional Manufacturer Narrative
On (b)(6) 2018 we were informed that the device is not available.
Event or Problem Description
The myknee tibial cutting block was not used due to impingement with the patellar tendon.The surgery was completed successfully using the conventional system.

• Brand Name: MYKNEE TIBIAL CUTTING BLOCK - SIZE 4
• Common Device Name: TIBIAL CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990399
• Report Number: 3005180920-2017-00632
• Device Sequence Number: 13760059
• Product Code: JWH
• UDI-Device Identifier: 07630030848711
• UDI-Public: 07630030848711
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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 Expiration Date: 03/16/2018
• Device Catalogue Number: 4.1084
• Device Lot Number: 56213K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 02/01/2018
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 70