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

Catalog Number	11.01002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 july 2019: lot 1902049, code 11.01002: 20 items manufactured and released on 20 mar 2019.Expiration date: 2024-03-06.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, 5 similar cases received up to now (this included).Preliminary investigation performed by medacta r&d project manager: during trial femoral positioning, one of the arm of the femoral impactor broke; the reason could be un excessive force applied through the handle during the instrument tightening.In this situation the two lateral harms could have been over stressed reducing resistance during impactions.Another factor that could have caused the breakage could be excessive lateral forcing trying to reposition in medio/lateral or flexo/recurvatum the final implant position or trying to complete the implant positioning using this femoral impactor extractor.The surgical technique recommends to use this instrument only to position and centering the femoral component on the resected femur but to not use it for final impactions.For this operation the surgeon has to use the femoral impactor assembled on the multifunctional handle.However, a new modification request was opened to manage an instrument update; with this design modification, the distribution of the forces during impactions will be improved thanks to a better congruency between femoral impactor and femoral components.
Event or Problem Description
When the surgeon impacts the trial femoral component, the femoral impactor/extractor claw broke.

• Brand Name: GMK SPHERE GENERAL MIS SET
• Common Device Name: INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8840208
• Report Number: 3005180920-2019-00645
• Device Sequence Number: 319101
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 03/06/2024
• Device Catalogue Number: 11.01002
• Device Lot Number: 1902049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/30/2019
• 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