MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, NATURAL

Model Number	G181H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Additional information was requested, and the following was obtained: what was the initial procedure? gyn.Surgery.What is the event day and procedure date?: (b)(6) 2020.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 gyn procedure on (b)(6) 2020, and suture was used.During the procedure, the suture and needle were separated.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/6/2021 an empty opened foil, a paper lid, a winding former with an partially dispensed suture and a detached needle of product were received for evaluation.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification and remnant suture was noted.The suture end was severely cut (damaged, frizzy), resulting in a clip off defect.No further functional test could be performed due to the condition of the returned device.The clip off defect has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking as part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.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, 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: GUT CHR UD 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10902534
• Report Number: 2210968-2020-09290
• Device Sequence Number: 16763735
• Product Code: GAL
• UDI-Device Identifier: 10705031037557
• UDI-Public: 10705031037557
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K946173
• 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,Followup
• Report Date (Section B): 11/02/2020

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: 02/29/2024
• Device Model Number: G181H
• Device Catalogue Number: G181H
• Device Lot Number: PCK931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1