MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8683G
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).A manufacturing record evaluation was performed for the finished device lot pjh576, and no non-conformances were identified.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 information was requested, but unavailable: what is the name of the initial procedure? what was used to complete the procedure? unfortunately i am unable to provide any additional information regarding this complaint.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was breaking.Patient involvement was unknown.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 04/28/2020.Additional information: h6.Corrected information: d3, g1, g2.Additional h-3 summary: four unopened samples of product were returned for analysts.The complaint sample was not received for evaluation.During the visual inspection of four 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 observed.A functional test was performed using a instron and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: PROLENE SUTURE 18"(45CM) 4-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9957412
• Report Number: 2210968-2020-03014
• Device Sequence Number: 16846233
• Product Code: GAW
• UDI-Device Identifier: 10705031018914
• UDI-Public: 10705031018914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 07/31/2024
• Device Model Number: 8683G
• Device Catalogue Number: 8683G
• Device Lot Number: PJH576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1