MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1916G
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 rhinoplasty procedure on an unknown date and suture was used.During the procedure, the suture broke off the needle.The suture tore while the surgeon was tying it.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: nine unopened samples of product were returned for analysis.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 strands with no defects or damage observed.Functional test was performed on the samples and the tensile strength force and pull 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 received, no suture needle pull off or suture breakage were found.

• Brand Name: GUT PL FAG UD 18IN 6-0 S/A PC-1 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: 8332430
• Report Number: 2210968-2019-78824
• Device Sequence Number: 16181722
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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: 07/31/2023
• Device Catalogue Number: 1916G
• Device Lot Number: MJZ989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1