MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8936H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
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.A manufacturing record evaluation was performed for the finished device batch qmbdtz, and no non-conformances were identified (b)(4).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 a cardiovascular procedure on (b)(6) 2021 and suture was used.During the procedure, the needle shredded off the suture.The procedure was successfully completed with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 8/3/2021.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.Additional information: d9, h6.Additional h3 investigation summary: visual analysis of the returned product revealed that one empty labeled winding former, one needle, and one needle/suture product code 8936 were received to ethicon inc for evaluation.The product code is double armed.Upon visual inspection of the returned sample, the swage and attachment were noted to be as expected and a suture piece still was attached to barrel hole.This suture piece was observed with damage and fraying due to use.Upon visual inspection, the needle/ suture, the swage, and attachement area of the needle were noted to be as expected, the end of the suture was observed cutted.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.As with any device, care should be taken to avoid damage to the strand when handling.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PROLENE SUTURE 36"(90CM) 3-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12083705
• Report Number: 2210968-2021-05892
• Device Sequence Number: 14328369
• Product Code: GAW
• UDI-Device Identifier: 10705031022102
• UDI-Public: 10705031022102
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/05/2021

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: 10/31/2025
• Device Model Number: 8936H
• Device Catalogue Number: 8936H
• Device Lot Number: QMBDTZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/05/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1