MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN USP4-0; SUTURE, NONABSORBABLE, SILK

Model Number	18515G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
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 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: what was the initial procedure? unknown.What is the event day and procedure date? unknown.What is the lot number? qcbher.Could you please confirm how many devices present the issue (pull off suture needle intra op) during this procedure? 2.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2020 and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 12/1/2020 additional information: d9, h6 a manufacturing record evaluation was performed for the finished device batch qcbher, 18515g55 and no non-conformances were identified.Additional h3 investigation summary: it was reported that suture pull-off during dispense from the needle.Suturing could not be done with the needle-suture.It was a control release needle.A needle piece and a needle/suture piece of product code 18515, lot qcbher were received for evaluation.During the visual inspection of the sample, the needle was noted broken at the swage area and marks of surgical instrument in this section could be observed.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 sample will undergo additional evaluation to determine the failure mode due to broken needle.Additinal h3 investigation summary: a suture needle was evaluated.The component was identified as product code 18515g.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.Additional h3 investigation summary: it was reported that suture pull-off during dispense from the needle.Suturing could not be done with the needle-suture.It was a control release needle.Seven unopened samples and an empty opened box of product code 18515, lot qcbher were received for evaluation.During the visual inspection of seven unopened samples, no defects were found 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.The device performed without any defect noted.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: SILK BLK 18IN USP4-0
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10686441
• Report Number: 2210968-2020-08046
• Device Sequence Number: 304427
• Product Code: GAP
• UDI-Device Identifier: 10705031088603
• UDI-Public: 10705031088603
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/07/2020

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: 02/28/2025
• Device Model Number: 18515G
• Device Catalogue Number: 18515G
• Device Lot Number: QCBHER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/02/2020
• Patient Sequence Number: 1