MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 7-0 D/A TG100-8; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1744G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number mgq067, and no non-conformances related to the reported complaint condition were identified.Device evaluation summary: a suture piece, an empty opened foil and an empty opened folder of product code 1744, lot #: mgq067, was returned for evaluation.This product code is double armed.During the visual inspection of the sample, the suture ends were noted cut appears to be by use of a surgical instrument and present body fluids along of the strand.The needles were not returned for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, it could not be determined what may have caused the reported incident.An empty opened box and six representative samples of product code 1744, lot #: mgq067, were returned for evaluation.During the visual inspection of six 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, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-84119, 2210968-2019-84122 and 2210968-2019-84126.Analysis results have been included in reports for each.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019, and suture was used.The needle popped off the suture at the swage.Another like device from a different box was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: GUT CHR UD 18IN 7-0 D/A TG100-8
• 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: 8782833
• Report Number: 2210968-2019-84122
• Device Sequence Number: 2639196
• Product Code: GAL
• UDI-Device Identifier: 10705031002333
• UDI-Public: 10705031002333
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 05/31/2023
• Device Catalogue Number: 1744G
• Device Lot Number: MGQ067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1