MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A X-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J458H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device and no non-conformances/ manufacturing irregularities related to the malfunction were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient had laparoscopic tension-free repair of left inguinal hernia on (b)(6) 2020 an the suture was used.During suturing, the suture broke.Another like device was used to complete the procedure.There were no patient consequences reported.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A X-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10951833
• Report Number: 2210968-2020-09611
• Device Sequence Number: 19640929
• Product Code: GAM
• UDI-Device Identifier: 10705031040052
• UDI-Public: 10705031040052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 04/30/2021
• Device Model Number: J458H
• Device Catalogue Number: J458H
• Device Lot Number: KEM713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/05/2020
• Patient Sequence Number: 1
• Patient Age: 50 YR