MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY TRIAL KEEL S5-6; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 may 2018.Lot 175809: (b)(4) items manufactured and released on 22 november 2017.Expiration date: 2022-11-06.No anomalies found related to the problem.No anomalies found related to the problem on (b)(4).To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved: impactor handle reference (b)(4), lot 175105.Lot 175105: (b)(4) items manufactured and released on 08 august 2017.Expiration date: 2022-7-24.No anomalies found related to the problem.No anomalies found related to the problem on (b)(4).To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During surgery the keel wing and the connection of the handle where holds the keel broke (the two yellow tabs).The surgeon used a secondary set of instruments to complete the surgery.
Additional Manufacturer Narrative
The piece invovled in the complaint is not available.A piece of the same lot stocked in the warehouse was analysed.Funtional control passed.No anomaly found during the dimensional control.

• Brand Name: GMK EFFICIENCY TRIAL KEEL S5-6
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7498735
• Report Number: 3005180920-2018-00311
• Device Sequence Number: 1775834
• Product Code: LXH
• UDI-Device Identifier: 07630030878572
• UDI-Public: 07630030878572
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 06/22/2018

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: 11/06/2022
• Device Catalogue Number: 11.01025
• Device Lot Number: 175809
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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