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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a hernioplasty surgery procedure on (b)(6) 2020 and suture was used.During subcutaneous closure, after putting 1 to 2 stitches, the surgeon noticed that there had been no needle.The needle was found on the floor.The needle had been detached from the suture.It was not a control release needle.There were no adverse consequences to the patient.No additional information was provided. .
Additional Manufacturer Narrative
(b)(6).Date sent to the fda: 09/28/2020 additional information: d10, h6 additional h3 investigation summary = > it was reported performance pull off - suture needle.An empty opened foil, a labeled winding former, a detached needle and a dispensed suture of product code j458, lot # lgz407 were returned for analysis.During the visual inspection of detached needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the opened sample, the assignable cause of the performance pull off - suture needle is a short insertion.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.

• 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: 10403402
• Report Number: 2210968-2020-06112
• Device Sequence Number: 14187501
• Product Code: GAM
• UDI-Device Identifier: 10705031040052
• UDI-Public: 10705031040052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 05/31/2022
• Device Model Number: J458H
• Device Catalogue Number: J458H
• Device Lot Number: LGZ407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1