MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1637G
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
(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 an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.No additional information was provided.
Additional Manufacturer Narrative
Pc-(b)(4).It was reported performance breakage suture.An opened box with nine unopened samples were returned for analysis.The issue sample was not returned for evaluation.During the visual inspection of nine unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area were as expected.The sutures were dispensed without problems and examined along of strands and no defects or damaged were observed.Functional test was performed on the samples and the tensile strength force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples no suture breakage were found.

• Brand Name: GUT CHR UD 18IN 4-0 S/A PS-2 PRM MP
• 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: 7885618
• Report Number: 2210968-2018-75879
• Device Sequence Number: 1819492
• Product Code: GAL
• UDI-Device Identifier: 10705031001503
• UDI-Public: 10705031001503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: 04/30/2023
• Device Catalogue Number: 1637G
• Device Lot Number: MEM862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/29/2018
• Patient Sequence Number: 1