MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, NATURAL

Catalog Number	G122H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
Event or Problem Description
It was reported that a patient underwent a gynecological procedure in (b)(6) 2018 and suture was used.During the procedure, the needle prematurely detached from the suture.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Representative samples were returned for analysis.There were no defects 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 strands and no defects were observed.Functional test was performed and the pull force were above the minimum requirements.Per the sample condition no needle pull off was found.

• Brand Name: GUT CHR UD 27IN 3-0 S/A SH
• 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: 7472358
• Report Number: 2210968-2018-72441
• Device Sequence Number: 16542307
• Product Code: GAL
• UDI-Device Identifier: 10705031037441
• UDI-Public: 10705031037441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 06/30/2022
• Device Catalogue Number: G122H
• Device Lot Number: LHM416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1