MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE FEMUR DISTAL CUTTING BLOCK; SURGICAL KNEE CUTTING BLOCK

Catalog Number	6.1025SM
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received by the sales representative on 11 december 2017: the patient was already under anesthesia, so additional anesthesia was needed to wait for re-sterilization of the my knee set.Only the packaging of the cutting guide has been received for investigation.Batch review performed on 10 january 2018 lot 60207k: (b)(4) items manufactured and released on 29 nov 2017.Expiration date: 2018-04-22 no anomalies found related to the problem.Visual inspection performed on 10 january 2018 by packaging and washing manager: the packaging and the picture received were analyzed and the event description confirmed.The two holes, respectively in the primary and the secondary packaging, could have been reasonably located in the same position if we consider the final configuration of the double-pouch packaging in force for the involved item.The failure seems to have been occurred due to forces experienced during the instrument transportation/ handling: in detail, the femur cutting block could have pierced the two pouches in the same time, as it is visible from the two packaging received.This could be correlated to the combination of the packaging configuration applied and the shape of the involved cutting block, as it presents some projecting parts.
Event or Problem Description
Outer and inner damaged my knee packaging.Femoral cutting block.Surgery delay of 1 hour.

• Brand Name: MYKNEE FEMUR DISTAL CUTTING BLOCK
• Common Device Name: SURGICAL KNEE CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7178511
• Report Number: 3005180920-2017-00822
• Device Sequence Number: 13476769
• Product Code: JWH
• UDI-Device Identifier: 07630030894794
• UDI-Public: 07630030894794
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/10/2018

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: 04/22/2018
• Device Catalogue Number: 6.1025SM
• Device Lot Number: 60207K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/10/2018
• 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
• Patient Age: 61 YR