MAUDE Adverse Event Report: ETHICON INC. STEEL SUTURE 18"(45CM) 7 B&S; SUTURE, NONABSORBABLE, STEEL

Catalog Number	D9499
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 mm5159, and no non-conformances were identified.Investigation summary: one opened box and seven unopened samples of product code d9499, lot mm5159 were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of seven 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 strands and no defects 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 condition of the samples, no pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent open heart surgery on (b)(6) 2019.During the procedure, the needle came off of the wire.An alternate device from a different box was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: STEEL SUTURE 18"(45CM) 7 B&S
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8824124
• Report Number: 2210968-2019-84626
• Device Sequence Number: 16779391
• Product Code: GAQ
• UDI-Device Identifier: 10705031033313
• UDI-Public: 10705031033313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: D9499
• Device Lot Number: MM5159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1