MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 4X27IN 2 S/A TP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J649G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (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: this happened with 2 of the 4 needles in the pack with 2 separate packets."could you please clarify if for the two defective devices are the same lot number? if not please provide the other lot number- yes they were the same lot number."these are a pack of sutures that have four separate needles in the pack.Four sutures were unswayed in total.(2 each from two separate packs)." 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.The event description states that the event, "during surgery after a few passes it was noted that the suture came away from the end of the needle.This happened with 2 of the 4 needles in the pack with 2 separate packets." is the total quantity involved was two sutures or four sutures? a manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.Event related to mw # 2210968-2022-10031.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.
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on (b)(6) 2022 and suture was used.During surgery, after a few passes, it was noted that the suture came away from the end of the needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 4X27IN 2 S/A TP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15929160
• Report Number: 2210968-2022-10033
• Device Sequence Number: 17242591
• Product Code: GAM
• UDI-Device Identifier: 10705031042018
• UDI-Public: 10705031042018
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: J649G
• Device Catalogue Number: J649G
• Device Lot Number: SEMMQP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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