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

Catalog Number	11.01036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 april 2018.Lot 171250: (b)(4) items manufactured and released on 06 march 2017.Expiration date: 2022-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event semifinished lot mat16658: 2400 items manufactured and released on 18 november 2015.No anomalies found related to the issue.Visual inspection performed on 20 april 2018 by (b)(4) product manager: the breaking of the trial keel could be due to different factors such as sclerotic bone, not enough preparation of the keel wings side with the risk of excessive impacting force for trial keel placement.During the visual inspection have also been analyzed the picture of the complaint.
Event or Problem Description
Trial keel breakage during surgery (wing broken).The patient had severe sclerotic bone.

• 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: 7446946
• Report Number: 3005180920-2018-00256
• Device Sequence Number: 16186198
• Product Code: LXH
• UDI-Device Identifier: 07630030878640
• UDI-Public: 07630030878640
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/20/2018

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: 02/21/2022
• Device Catalogue Number: 11.01036
• Device Lot Number: 171250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• 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: 54 YR
• Patient Weight: 95