MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8889H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device for evaluation.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: it was reported that this issue occurred 2 times or more: please provide specific number of devices with sutures broken in a single procedure.No further information is available.Please open separate product complaints if multiple procedures are reported in this complaint.This issue occurred in one procedure.Device return status/ follow up: we regularly contact with sales rep about the device returning.No further information will be provided.Events were submitted via 2210968-2020-04259 and 2210968-2020-04260.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.It was reported that the suture was broken easily during continuous suturing.There were no adverse consequences to the patient.No additional information is available.
Additional Manufacturer Narrative
Date sent to the fda: 06/29/2020.Additional information: d10, h6.A manufacturing record evaluation was performed for the finished device pkr426 batch number, and no non-conformances were identified.Additional h-3 summary: it was reported performance breakage suture.An opened box with twenty-one unopened samples of product were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of thirteen 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 using an instron and the tensile strength force was above the minimum requirement.Per the condition of the samples received, no performance - breakage suture was found and the tested samples met the finished goods requirements.Additional information was requested, and the following was obtained: please provide specific number of devices with sutures broken in a single procedure.- qty involved: 2 (they were not returned).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 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: 10103015
• Report Number: 2210968-2020-04260
• Device Sequence Number: 16762100
• Product Code: GAW
• UDI-Device Identifier: 10705031021754
• UDI-Public: 10705031021754
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/20/2020

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: 08/31/2024
• Device Model Number: 8889H
• Device Catalogue Number: 8889H
• Device Lot Number: PKR426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1