MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE FEMUR DISTAL CUTTING BLOCK - CT -- GMK - LEFT MEDIAL - SIZE3+

Catalog Number	4.1013M
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Document review performed on 17-may-2018: lot 65614k: (b)(4) items manufactured and released on 04-april-2018.Expiration date: 2018-10-21.No anomalies found related to the issue.Other item involved: myknee femur distal cutting block - ct -- gmk - left medial - size 3+ reference (b)(4).Lot 65615k: (b)(4) items manufactured and released on 06-april-2018.Expiration date: 2018-10-21.No anomalies found related to the problem.
Event or Problem Description
After the patient was put under anaesthesia, the agent noticed that the wrong myknee blocks were in the case.The surgeon rescheduled the case to a later date.The blocks brought in error were for the surgery with patient (b)(6) that were supposed to be for the patient (b)(6) who is scheduled on (b)(6).

• Brand Name: MYKNEE FEMUR DISTAL CUTTING BLOCK - CT -- GMK - LEFT MEDIAL - SIZE3+
• Common Device Name: CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7522293
• Report Number: 3005180920-2018-00335
• Device Sequence Number: 19230111
• Product Code: JWH
• UDI-Device Identifier: 07630030865855
• UDI-Public: 07630030865855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/17/2018

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: 10/21/2018
• Device Catalogue Number: 4.1013M
• Device Lot Number: 65614K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• 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