MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	H821H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.Attempts are being made to obtain the following information.Could you please advise how the procedure was completed, any adverse event to patient due to this fault, how the procedure was completed.To date no response has been provided.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2018 and a suture was used.During surgery, the suture was broken.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A box with thirty-three unopened samples of product code (b)(4), lot lpz310 were received for analysis.The issue sample was not returned.During the visual inspection of thirteen samples, no defects were found on the packages.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.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: GUT PL UD 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8042029
• Report Number: 2210968-2018-76965
• Device Sequence Number: 19213780
• Product Code: GAL
• UDI-Device Identifier: 10705031037779
• UDI-Public: 10705031037779
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K946173
• 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): 10/08/2018

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: 11/30/2022
• Device Catalogue Number: H821H
• Device Lot Number: LPZ310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/04/2018
• Patient Sequence Number: 1