GENTRIX SURGICAL MATRIX THICK

Additional Manufacturer Narrative

THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED SUTURE PULL THROUGH THAT OCCURRED DURING THE INITIAL PLACEMENT OF THE ACELL DEVICE. THE DEVICE WAS THEREFORE NOT USED, THE SURGEON REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER WHICH RESULTED IN A DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH. THE DEVICE WAS RETURNED TO ACELL FOR FURTHER INVESTIGATION, SUTURE PULL THROUGH COULD NOT BE DUPLICATED ON THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATIONS.

Description of Event or Problem

ON (B)(6) 2018, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A INCISIONAL HERNIA REPAIR. CONTRARY TO THE DEVICE'S INSTRUCTIONS FOR USE (IFU), THE DEVICE WAS HYDRATED FOR 25 MINUTES AND IN A 100 DEG FAHRENHEIT WARMER. THE IFU SPECIFIES TO HYDRATE THE DEVICE IN A STERILE DISH WITH ROOM TEMPERATURE STERILE SALINE FOR A MINIMUM OF 30 MINUTES AND MAXIMUM 60 MINUTES. THE SURGEON SECURED ONE SIDE OF THE MESH WITH A 1 CTX BRAIDED SUTURE; HOWEVER, WHEN THE SURGEON BEGAN TO SECURE THE OTHER SIDE DOWN, THE SUTURE PULLED THROUGH ON THE INITIALLY SECURED SIDE OF THE DEVICE. THE DEVICE WAS NOT USED. THE SURGEON REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.