MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX PLUS

Model Number MSPL0507

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

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 not used, the surgeon decided to close the hernia primarily 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.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.

Event Description

On (b)(4) 2019, acell, inc.Became aware that suture pull through occurred with an acell device during the reinforcement of a umbilical hernia repair.The device was not used.The surgeon decided to close the hernia primarily 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.

• Brand Name: GENTRIX SURGICAL MATRIX PLUS
• Type of Device: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 8659456
• MDR Text Key: 146702556
• Report Number: 3005920706-2019-00010
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001226
• UDI-Public: (01)00386190001226(17)200731(10)013335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: MSPL0507
• Device Catalogue Number: MSPL0507
• Device Lot Number: 013335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other