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	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Document review performed on 12 april 2018: lot 177042 : (b)(4) items manufactured and released on 06 february 2018 expiration date: 2023-01-25; no anomalies found related to the problem and no anomaly found related to the problem on mat 22341; to date, (b)(4) items of the same lot have been already sold without any similar reported event.Prelimary investigation performed on 12 april 2018 by r&d product manager: the breakage 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.
Event or Problem Description
During surgery when the surgeon was impacting the keel, the wing of the instrument broke.The surgeon used a secondary instrument to complete the surgery.

• 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: 7425027
• Report Number: 3005180920-2018-00230
• Device Sequence Number: 16638451
• 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): 04/12/2018

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: 01/25/2023
• Device Catalogue Number: 11.01025
• Device Lot Number: 177042
• 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: 03/14/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: 59 YR