MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 1620002

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Qa investigation into lot sp100230 resulted in no remarkable findings including all (b)(4) devices distributed with no other complaints reported against the lot and no deviations or nonconformances revealed during processing.Lot sp100230 met all qc release criteria including mechanical testing and thickness.The evaluation of the returned device performed by lifecell's product development department concluded through thickness measurements that the regions where the device tore were not deemed to be excessively thin for typical strattice firm pieces.Based on the results of this investigation including the device evaluation, a nonconformance was not confirmed.This event is being reported due to the extended surgical time to replace the device.

Event Description

It was reported that during a hernia repair procedure on (b)(6) 2016, the strattice had split while the surgeon was implanting it into the patient.The assisting surgeon reported that the strattice was explanted and replaced with surgimend 3.0 to complete the case and that he did not feel any excessive tension was on the device at the time of the tear.The surgery was reported to be prolonged about three hours.Currently, the patient is doing well.The strattice was explanted and returned to lifecell for an evaluation.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: stanley dube ; one millennium way; branchburg, NJ 08876 ; 9089471575
• MDR Report Key: 5843614
• MDR Text Key: 52395404
• Report Number: 1000306051-2016-00044
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: 1620002
• Device Catalogue Number: N/A
• Device Lot Number: SP100230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2015
• 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