MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	K871H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested and the following was obtained: please clarify what is the specific issue with the device during this procedure? dental surgery.Did the suture detach from the needle? needle rupture.Did the needle break? yes.What tissue was being approximated or sutured when it broke? at the first suture.Was the needle removed from the patient during the same procedure? yes.
Event or Problem Description
It was report that a patient underwent dental surgery on an unknown date during 2021 and suture was used.During the procedure, the needle broke at the first suture.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 7/26/2021.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.A manufacturing record evaluation was performed for the finished device batch qbbqcl, and no non-conformances were identified additional information: d4, d9, h4, h6.Additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: one opened sample of product code k871h was returned to ethicon inc for analysis.In order to evaluate the conditions of the returned sample, the swage and attachment area were noted to be as expected.The needle was examined and no breakage on body, tip or swage area were observed during evaluation.Functional test was performed, to needle by resistance and met the 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, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Thirty-four packets of product code k871h were returned for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packet.In order to evaluate the conditions of thirteen samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The needle was intact and no damages or breakage on body, tip or swage area were observed during evaluation.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 batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: SILK SUTURE 30"(75CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11973383
• Report Number: 2210968-2021-05409
• Device Sequence Number: 4269446
• Product Code: GAP
• UDI-Device Identifier: 10705031044562
• UDI-Public: 10705031044562
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 01/31/2025
• Device Model Number: K871H
• Device Catalogue Number: K871H
• Device Lot Number: QBBQCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1