MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY - TRIAL KEEL S3-4; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 july 2017.Lot 170359: (b)(4) items manufactured and released on 25 january 2017.Expiration date: 2022-01-11.No anomalies found related to the problem on mat16649.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.On 14 july 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: the cause of the gmk efficiency trial keel breakage could be the excessive load on the keel wings due to sclerotic bone or due to excessive force during impactions (in the claim is reported" the bone was extremely dense").The surgical technique recommends to prior prepare the tibial plate by using the oscillating saw before impactions in order to reduce the lateral force on the trial tibial keel wings (step correctly followed by the surgeon).The pictures show a jagged fracture compatible with flexion stress probably caused by a not correct direction of impactions.
Event or Problem Description
When surgeon was using the tibial keel punch the keel broke.Per the surgeon the patient had hard bone.No fragments fell into the patient.The surgeon used a metal keel out of another set.There was a delay of less than 5 minutes.The surgery was completed successfully instrumentation is available.

• Brand Name: GMK EFFICIENCY - TRIAL KEEL S3-4
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6714196
• Report Number: 3005180920-2017-00382
• Device Sequence Number: 220748
• Product Code: LXH
• UDI-Device Identifier: 07630030878565
• UDI-Public: 07630030878565
• 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): 07/14/2017

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: 01/11/2022
• Device Catalogue Number: 11.01024
• Device Lot Number: 170359
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/14/2017
• 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: 70 MO