MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK EFFICIENCY FEMORAL CUTTING GUIDE 4IN1 S4+; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	11.01114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 february 2018.(b)(4).Preliminary investigation performed on 20 february 2018 by r and d project manager: it is not possible to determine the real cause of the complaint in the absence of the piece.The pieces included in the batch mat 16601 resulted in compliance to the current control plan.The surgical technique recommends to refrigerate the saw blade during resection in order to avoid overheat of the cutting guide with the risk of deformation.The surgeon has also to verify the compatibility between the cutting slot and the saw blade before to introduce and use t to prevent damage and wear of the guide with the risk of release of plastic debris.
Event or Problem Description
The slit of 4in1 cutting guide was shaved during femoral bone cut with 1.19 mm bone saw blade.The plastic debris detached from the guide were removed through a wash out.

• Brand Name: GMK EFFICIENCY FEMORAL CUTTING GUIDE 4IN1 S4+
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7282357
• Report Number: 3005180920-2018-00070
• Device Sequence Number: 16407730
• Product Code: LXH
• UDI-Device Identifier: 07630030877414
• UDI-Public: 07630030877414
• 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: Other
• Type of Report: Initial

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: 10/01/2022
• Device Catalogue Number: 11.01114
• Device Lot Number: 175791
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• 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