MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE FEMUR DISTAL CUT BLOCK - GMK SPHERE - LEFT MEDIAL - SIZE 3+; FEMORAL CUTTING BLOCK

Catalog Number	4.3613M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 november 2017.Lot 58334k: (b)(4) items manufactured and released on 09 october 2017.Expiration date: 2018-04-19.No anomalies found related to the problem.To date, no other events have been reported on items of the same lot.On 21 november 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: the slot of the distal cutting guide is completely worn out because of the excessive friction between saw blade and the guide; the saw blade is blocked into the slot because of the presence of the plastic debris.In this condition it is not possible to correctly measure the real dimension of the cutting slot.We also measured the thickness of the used blade; at the cutting edges the dimension is till 1.35 ÷ 1.4 mm (there are a few points of the blade where dimension assumed as 1.27 mm is not conformed but we can not establish if the damage of the blade was caused trying to disengage the blade from the cutting slot by using other instruments).The dimension of the my knee cutting slots are 100% functionally checked with a 1.27 blade; for these reasons it is not possible to determine with certainty that the cause is the cutting slot instead of the saw blade.
Event or Problem Description
The slot of the myknee femoral cutting guide was too tight.Even though the surgeon used a saw blade of a proper thickness (1.27 mm), it was almost impossible to perform the femoral distal cut.Because of the tightness of the slot, the myknee cutting block partially melt around the saw blade.The surgeon was forced to finish the distal cut using the conventional cutting block (the metallic one), causing a delay of operating time of about 5 minutes.

• Brand Name: MYKNEE FEMUR DISTAL CUT BLOCK - GMK SPHERE - LEFT MEDIAL - SIZE 3+
• Common Device Name: FEMORAL CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7052122
• Report Number: 3005180920-2017-00689
• Device Sequence Number: 1424081
• Product Code: JWH
• UDI-Device Identifier: 07630030870293
• UDI-Public: 07630030870293
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093806
• 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
• Report Date (Section B): 11/22/2017

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: 04/19/2018
• Device Catalogue Number: 4.3613M
• Device Lot Number: 58334K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/22/2017
• 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
• Patient Age: 81 YR
• Patient Weight: 80