MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Model Number	M649G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2022 and suture was used.Before use on the patient, when a scrub nurse opened the package, it was found that the needle had been detached from the wire.It was not a control release needle.Further details are not provide.Upon evaluation of the returned device, after investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.No adverse patient consequences were reported.No additional information was requested.
Additional Manufacturer Narrative
(b)(4).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 lot, and no non-conformances were identified.Analysis: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that one opened sample with three needle-suture, one detached needle, and one suture that pertains to product code m649g were returned for analysis.The product code is multistrand and each packet contains four strands single-armed.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.During the visual inspection of the three needle- sutures, the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed using instron equipment, and the pull force on one sample did not meet the requirement.After investigation of the sample short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.In the rest, the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through quality system.

• Brand Name: STLESS STEEL SIL 4X18IN 6 S/A V-40
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16039163
• Report Number: 2210968-2022-10588
• Device Sequence Number: 20241412
• Product Code: GAQ
• UDI-Device Identifier: 10705031045415
• UDI-Public: 10705031045415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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 Model Number: M649G
• Device Catalogue Number: M649G
• Device Lot Number: SDBERU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown