MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8762H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in mwr- 2210968-2020-10217, 2210968-2020-10218.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and a suture was used.During the procedure, the suture pulled off the needle.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: 3/2/2021.A manufacturing record evaluation was performed for the finished device batch qbbptk and no non-conformances were identified.H6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample double-armed of product code 8762h was received for evaluation, the swage and attachment area were as expected, and the remnant of the suture was noted into the barrel hole, and marks were observed on the body and edge of the needles that appears to be by the use of a surgical instrument.In addition, the ends of the suture were cut appears to be by use of the surgical instrument.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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Two sealed boxes (36 ea.) and an opened box with fourteen unopened samples were returned to ethicon inc for evaluation.Visual inspection and functional testing were conducted on thirteen returned devices.Visual analysis of the returned samples revealed that the 8762h samples were returned with no apparent damage on the packages.The samples were opened, and 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 or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.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.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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) 3-0 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: 11060162
• Report Number: 2210968-2020-10215
• Device Sequence Number: 3261018
• Product Code: GAW
• UDI-Device Identifier: 10705031020320
• UDI-Public: 10705031020320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/09/2020

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: 8762H
• Device Catalogue Number: 8762H
• Device Lot Number: QBBPTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1