MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE GENERAL MIS SET; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.01002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot: 1901036, code 11.01002: (b)(4) items manufactured and released on 22 february 2019.Expiration date: 2024-02-21.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold.Concerning the semi-finished device subject of this case: code 77.11.0063, lot mat27910: (b)(4) items manufactured and released on 20 december 2018.No anomalies found related to the issue, 3 similar cases received up to now.Preliminary investigation performed by r&d project manager: from the analysis of the images it is not possible to identify the real cause of the breakage.We can imagine that the breakage could be happened due to excessive tightening force applied during femoral implant fixation and/or , the surgeon tried to adjust the flexion of the femoral component.In any case we are investigate a new design of the impacting head in order to increase the radii of the external shape, increasing the surface in contact with the femoral component and increasing the resistance section of the device.
Event or Problem Description
During the primary knee surgery, the gmk efficiency femur impactor broke while the surgeon was trying to place the femoral component.No fragments fell into the patient and the surgeon was able to impact the implant with a metal femoral impactor.There was no delay in the case and the surgery was completed successfully.

• Brand Name: GMK SPHERE GENERAL MIS SET
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8707535
• Report Number: 3005180920-2019-00478
• Device Sequence Number: 16774984
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 02/21/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1901036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/18/2019
• 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