MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 3X18IN 1 S/A OS-8 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J757T
Medical Device Problem Code	Material Separation (1562)
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
Product complaint # (b)(4).Component code: (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.Additional information was requested, and the following was obtained: please provide procedure name and date.Unk.How many sutures separated from the needle during suturing on this one patient during this single surgical procedure? unk.It is stated: "two different surgeons stated that the suture is coming apart from the needle too easily".What is the total number of patients? unk.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.Please provide lot number.Please provide status of product return.The materials coordinator that reported this to me told me that she had complaints from 2 different surgeons that this was occurring and it all was from the same box/lot number.I opened one and the needle did come off with very little force.The customer did not want to use any more from this box and what was left was sent back in for analysis.The exact number that happened during procedures is unknown but the customer wants the entire box replaced.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.During the procedure, the suture got detached from the needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 3X18IN 1 S/A OS-8 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12516857
• Report Number: 2210968-2021-08772
• Device Sequence Number: 3078692
• Product Code: GAM
• UDI-Device Identifier: 10705031042797
• UDI-Public: 10705031042797
• 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): 08/25/2021

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 Model Number: J757T
• Device Catalogue Number: J757T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1