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

Model Number	PSMT1620
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: GENTRIX SURGICAL MATRIX THICK
• Common Device Name: GENTRIX SURGICAL MATRIX THICK
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr; columbia MD 21046
• MDR Report Key: 7802057
• Report Number: 3005920706-2018-00011
• Device Sequence Number: 19310139
• Product Code: OXH
• UDI-Device Identifier: 00386190001790
• UDI-Public: (01)00386190001790(17)191130(10)010957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: PSMT1620
• Device Catalogue Number: PSMT1620
• Device Lot Number: 010957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/21/2018
• 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: Hospitalization; Other
• Patient Age: 66 YR