MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 7-0 D/A TG160-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J576G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that "during a hypospadias repair procedure the needle was popping off multiple sutures".Could you please confirm the quantity of devices that presented this issue (needle pull off from suture) during this procedure? what was being done when the pull off occurred (e.G.Removal from package, during passage through tissue, during tying, etc.)? the product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned samples determined that an opened box with four unopened samples of product code j576g were received for evaluation.Visual inspection of the unopened samples and no defects were found on the package.The samples were opened, and 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 and the pull force was above the minimum requirements.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number qgmaxl, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that a patient underwent a hypospadias procedure (b)(6) 2021 and suture was used.During the surgery, the needle was popping off multiple sutures.Another like device of a different lot was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 18IN 7-0 D/A TG160-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11609635
• Report Number: 2210968-2021-02995
• Device Sequence Number: 3021075
• Product Code: GAM
• UDI-Device Identifier: 10705031041387
• UDI-Public: 10705031041387
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 05/31/2025
• Device Model Number: J576G
• Device Catalogue Number: J576G
• Device Lot Number: QGMAXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1