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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 may 2018 lot 164266: (b)(4) items manufactured and released on 07 july 2016.Expiration date: 2021-06-23 no anomalies found related to the problem.No anomalies found on (b)(4).To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved is trial keel s5-6: lot 177048: (b)(4) items manufactured and released on 17 january 2018.Expiration date: 2023-01-02 no anomalies found related to the problem.No anomalies found related to the problem also on (b)(4).To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by 02 may 2018 by r&d 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 complain.
Event or Problem Description
During a gmk-efficiency bilateral case, the keels for both the knees broke (the medial side of one keel and the lateral fin of the other one).Conventional instruments used to complete the surgery successfully.10min delay.No fragments fell into the patient.

• 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: 7479656
• Report Number: 3005180920-2018-00291
• Device Sequence Number: 16513104
• 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
• Report Date (Section B): 05/02/2018

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: 06/23/2021
• Device Catalogue Number: 11.01025
• Device Lot Number: 164266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 05/02/2018
• 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: 55 YR