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

Catalog Number	RM1016BIO
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• MDR Report Key: 6218300
• Report Number: 1416980-2016-18942
• Device Sequence Number: 15182108
• Product Code: FTM
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2017
• Device Catalogue Number: RM1016BIO
• Device Lot Number: SPCE315-02B0066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/25/2017
• 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: Other