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

Catalog Number	11.01002
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: set ref (b)(4), lot 189881: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-12-04.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.As regards the specific impactor handle lot mat25715, no other similar case has ever been registered.Preliminary investigation performed by r&d product manager: from the analysis of the image, it is not possible to identify the real cause of the instrument breakage.We may suppose that the breakage occurred after several impactions with different devices (trial keel, tibia impactor, femoral impactor); in case the handle was not completely or correctly assembled with the impactors, the t shape connection could be forced in a wrong way till the breakage.A second hypothesis could be the application of excessive force or lateral impactions (e.I.To adjust the medio lateral position of the trial femoral component) with the risk of deformation/breakage of the jello handle connection.
Event or Problem Description
During the primary knee surgery, the yellow tip of the efficiency impactor handle broke while the surgeon was impacting the femoral trial.No fragments fell into the patient and there was no delay in the case.The surgery was completed successfully.

• Brand Name: GMK EFFICIENCY IMPACTOR HANDLE
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8343135
• Report Number: 3005180920-2019-00057
• Device Sequence Number: 16675888
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 12/18/2018
• Device Catalogue Number: 11.01002
• Device Lot Number: 189881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• 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