MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY FEMORAL IMPACTOR; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	11.01001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 february 2019: general sphere instrument set 11.01001, lot 1810883: (b)(4) items manufactured and released on 03-jan-2019.Expiration date: 2023-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Considering the (b)(4), this is the first case of breakage received.Preliminary investigation performed by r&d project manager: the breakage of the femoral impactor was probably caused by excessive impacting force.In case of lateral impactions or with the impactor not perfectly aligned and in contact with the femoral component surface, the external edge could be damaged till the breakage.
Event or Problem Description
During the primary knee surgery, the femoral impactor broke while impacting the femur.A fragment fell into the patient but the surgeon was able to recover it.The surgeon successfully impacted the femur without having to swap to a different impactor and there was no delay in the case.The surgery was completed successfully.

• Brand Name: GMK EFFICIENCY FEMORAL IMPACTOR
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8381779
• Report Number: 3005180920-2019-00113
• Device Sequence Number: 16888434
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 12/12/2023
• Device Catalogue Number: 11.01001
• Device Lot Number: 1810883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• 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