MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 8-0 D/A BV175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8754H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
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.Procedure name and date? what tissue was being approximated or sutured when it broke? what was used to complete the procedure? 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 (b)(6) 2020; and a suture was used.During the procedure, the suture broke easily.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 12/03/2020.H6 component code: g07002 ¿ conforming device.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: an opened box with twenty-three unopened samples of product were received for evaluation.During the visual inspection, 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.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 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: PRLNE BLU 30IN 8-0 D/A BV175-8 MP
• 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: 10791905
• Report Number: 2210968-2020-08719
• Device Sequence Number: 3680314
• Product Code: GAW
• UDI-Device Identifier: 10705031020214
• UDI-Public: 10705031020214
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 8754H
• Device Catalogue Number: 8754H
• Device Lot Number: PKH077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1