MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 6-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J499G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mice underwent a surgical procedure on (b)(6) 2021 and suture was used.The sutures will not stay together.The braid comes undone, constantly breaks, and will not hold together the internal skin.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) a manufacturing record evaluation was performed for the finished device lot number rbmbta and no non-conformances related to the reported complaint condition were identified (b)(4).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: ¿ could you please provide more details about how "the braid comes undone"? looking at the suture while still in the package, the individual strands are noticeably not tight together.As we would pass the suture through the mouse internals, the braid becomes noticeably unwound ¿ gaps can be seen through the individual strands.At this point, the sutures would continuously break while attempting to tie off the suture and/or would snap apart once a suture was already in place when another suture was being added.¿ did the suture separate completely? it never got to the point where the individual strands were completely unwound from each other, but like mentioned above gaps would form between the strands.Some large enough that i could stick my forceps through the hole.¿ could you please provide the lot number? the lot number is rbmbta, expiration date 2026-01-31.¿ did the event occur during one or multiple patient procedures? occurred at two different procedures.¿ what is the total number of procedures? two procedures, each with 20 mice ¿ for a total of 40 mice.During these surgeries we use at least a box and a half of j499 ¿ for a total of 3 boxes.¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No, these events have not been previously reported.¿ if this event occurred in multiple procedures, please provide the following information for each procedure: as the type of procedure was the same, i will provide details for the both when applicable but the description occurred at both procedures.Event date (b)(6) 2021 & (b)(6) 2021 procedure date (b)(6) 2021 & (b)(6) 2021 product used in procedure j499 quantity of each product used 1 ½ boxes per procedure = 3 boxes in total event description stating when each involved device had an issue in the procedure we perform abdominal surgeries on mice and use this product for the internal skin closure.As we would pass the suture through the mouse internals, the braid becomes noticeably unwound ¿ gaps can be seen through the individual strands.At this point, the sutures would continuously break while attempting to tie off the suture and/or would snap apart once a suture was already in place when another suture was being added.**note, we have used this product for at least an additional ~8 procedures/surgeries over the past ~year and have not had this problem before.Additional information was requested and the following was obtained: please clarify the exact number of sutures that broke during suturing during the procedure on (b)(6) 2021.At a minimum, the sutures broke 60 times across the 21 packs of sutures we used for this surgery.As a note, we do use the same suture across a few animals, therefore the larger number is the combined total of times a suture snapped/broke during the surgery.The smaller number being the exact number of individual suture packets that were used.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events from (b)(6) 2021 procedure reported via 2210968-2021-07243, 2210968-2021-08165, 2210968-2021-08166, 2210968-2021-08167, 2210968-2021-08168, 2210968-2021-08169, 2210968-2021-08170, 2210968-2021-08171, 2210968-2021-08172, 2210968-2021-08173, 2210968-2021-08175, 2210968-2021-08176, 2210968-2021-08177, 2210968-2021-08178, 2210968-2021-08179, 2210968-2021-08180, 2210968-2021-08181, 2210968-2021-08182, 2210968-2021-08183, 2210968-2021-08184, and 2210968-2021-08185.

• Brand Name: VCL CT BRD UD 18IN 6-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12443576
• Report Number: 2210968-2021-08185
• Device Sequence Number: 19801768
• Product Code: GAM
• UDI-Device Identifier: 10705031040663
• UDI-Public: 10705031040663
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: 01/31/2026
• Device Model Number: J499G
• Device Catalogue Number: J499G
• Device Lot Number: RBMBTA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1