MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 4-0 D/A SC-1; SUTURE, ABSORBABLE, NATURAL

Model Number	1828H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).No problem detected.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: was reported the suture broke while trying to tie the incision close.Unopened samples of product code 1828, lot #: qemetc were received for evaluation.During the visual inspection of eight unopened samples, no defects were found on the package.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.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.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 an ent procedure in (b)(6) 2020 and suture was used.The suture broke while trying to tie the incision closed.Case completed with a like device.There were no adverse patient consequences reported.

• Brand Name: GUT PL UD 18IN 4-0 D/A SC-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: 11032610
• Report Number: 2210968-2020-10074
• Device Sequence Number: 1087452
• Product Code: GAL
• UDI-Device Identifier: 10705031002661
• UDI-Public: 10705031002661
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2020

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: 04/30/2025
• Device Model Number: 1828H
• Device Catalogue Number: 1828H
• Device Lot Number: QEMETC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1