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

Catalog Number	PDP371T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an unopened sample of product code pdp371, lot # mdm597 was returned for analysis.During the visual inspection of the sample, no defects were found on the packages.The sample was opened, and swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested sample met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number mdm597, and no non-conformances related to the reported complaint condition were identified.Representative sample returned to support investigation of 3 device issues captured in reports 2210968-2019-86340, 2210968-2019-86341 and 2210968-2019-86342.Analysis results have been included in initial reports for each.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2019 and suture was used.The suture would break when the surgeon went to tie it.Another device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: PDS+ VIO 36IN 1 S/A CTX
• 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: 8937159
• Report Number: 2210968-2019-86341
• Device Sequence Number: 10870347
• Product Code: NEW
• UDI-Device Identifier: 10705031048201
• UDI-Public: 10705031048201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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 Expiration Date: 03/31/2020
• Device Catalogue Number: PDP371T
• Device Lot Number: MDM597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/27/2019
• Patient Sequence Number: 1