MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FIXED TIBIAL INSERT SC SIZE 3/10MM

Catalog Number	02.07.0310SCF
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 09 january 2018: (b)(4).
Event or Problem Description
During surgery when the surgeon went to seat the insert, it wouldn't seat.The surgeon used a secondary medacta's insert which was implanted with no issue.

• Brand Name: FIXED TIBIAL INSERT SC SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7185376
• Report Number: 3005180920-2017-00836
• Device Sequence Number: 1274716
• Product Code: JWH
• UDI-Device Identifier: 07630030817076
• UDI-Public: 07630030817076
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• 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): 01/12/2018

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: 10/05/2020
• Device Catalogue Number: 02.07.0310SCF
• Device Lot Number: 155560
• 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: 12/14/2017
• Initial Report FDA Received Date: 01/12/2018
• 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