MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8412H
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).A manufacturing record evaluation was performed for the finished device lot (b)(4), and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please provide the specific number of devices with suture breakage in this procedure.3 how was case completed? with same like product.Note: events reported in 2210968-2020-00307, 2210968-2020-00308, and 2210968-2020-00309.
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on an unknown date and suture was used.During the procedure, the suture broke with only slight tension.Another like device was used to complete the procedure.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 03/03/2020.Additional information: a needle-suture piece of product was returned for analysis.During the visual inspection of the used needle-suture piece, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture piece busted were observed.Also, body fluids and slice at the end due to use were noted.Additional, per the condition of the sample the functional test can¿t be performed.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Representative samples: an empty opened box and seven unopened samples of product was returned for analysis.During the visual inspection of unopened 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.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 30"(75CM) 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: 9581454
• Report Number: 2210968-2020-00308
• Device Sequence Number: 595732
• Product Code: GAW
• UDI-Device Identifier: 10705031015265
• UDI-Public: 10705031015265
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133356
• 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): 12/17/2019

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: 02/29/2024
• Device Model Number: 8412H
• Device Catalogue Number: 8412H
• Device Lot Number: PCH662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1