MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	ZB371
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn procedure on (b)(6) 2018 and suture was used.During the procedure, the suture broke during continuous suturing.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4).An empty opened folder and a dispensed suture of product were returned for analysis.The needle was not sent.During the visual inspection of sample, the suture was examined along of the strand and no defects or suture breakage were observed, however the ends of the suture were observed cut appears to be by use of the surgical instruments.A functional test was performed using a instron and the tensile force, were above the minimum requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.Per the condition of the sample received, no performance breakage suture were found and the tested sample met the finished goods requirements and the reported.

• Brand Name: PDSII VIO 36IN 1 S/A CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7565640
• Report Number: 2210968-2018-73270
• Device Sequence Number: 2687418
• Product Code: NEW
• UDI-Device Identifier: 10705031062078
• UDI-Public: 10705031062078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZB371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1