MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24IN (60CM) 8-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	PN3741LG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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.The following additional information was obtained: the 5 threads broken during the same single procedure.No patient consequence.The box of thread has been changed.Note: events reported via medwatch 2210968-2019-83069, 2210968-2019-83070, 2210968-2019-83071, 2210968-2019-83072.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, suture broke.A like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h3: it was reported that the device had breakage suture issue.An empty opened box and seven unopened samples were returned for analysis.The complaint sample was not returned.During the visual inspection of seven samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.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 samples met the finished goods requirements.Representative samples returned to support investigation of 5 device issues captured in reports 2210968-2019-83069, 2210968-2019-83070, 2210968-2019-83071, 2210968-2019-83072, 2210968-2019-83073.Analysis results have been included in follow-up reports for each.

• Brand Name: PRONOVA SUTURE 24IN (60CM) 8-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8719559
• Report Number: 2210968-2019-83073
• Device Sequence Number: 2211547
• Product Code: GAW
• UDI-Device Identifier: 10705031238374
• UDI-Public: 10705031238374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001625
• 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): 05/28/2019

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: 09/30/2023
• Device Catalogue Number: PN3741LG
• Device Lot Number: MLH419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1