MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS; MESH, SURGICAL

Catalog Number RM1016BIO

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The exact date of the veritas tear was not reported; however, it was reported that it was initially implanted in a surgery on (b)(6) 2016.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient with a veritas implant experienced a tear in the suture line after an unspecified surgery.On an unspecified day after the initial surgery, the patient underwent a recurring surgery where it was discovered that the veritas had failed and had a tear.The implant had to be replaced.It is unknown whether the second surgery was needed as a result of the failure of the product or if the tear was simply noted during the second surgery.No additional information was provided regarding patient outcome.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; ni; saint paul MN 55144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6218300
• MDR Text Key: 63726835
• Report Number: 1416980-2016-18942
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2017
• Device Catalogue Number: RM1016BIO
• Device Lot Number: SPCE315-02B0066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other