MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8701H
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).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide lot number.Please provide procedure name and date.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.During the procedure, the suture broke too easily.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/19/2020.Additional information: d4, d10, g1, h4, h6.A manufacturing record evaluation was performed for the finished device lot number qbbqpr/8701h56, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: it was reported that the suture was breaking too easily.An opened box with thirty-four unopened samples of product code 8701h lot # qbbqpr were received for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the package.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.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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, or its employees that the report constitutes an admission that the product, ethicon, 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 18"(45CM) 7-0 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: 10741922
• Report Number: 2210968-2020-08366
• Device Sequence Number: 3312741
• Product Code: GAW
• UDI-Device Identifier: 10705031019294
• UDI-Public: 10705031019294
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 01/31/2025
• Device Model Number: 8701H
• Device Catalogue Number: 8701H
• Device Lot Number: QBBQPR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1