MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 5 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M653G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a cabg on (b)(6) 2018 and suture was used for sternum closure.During the procedure, the suture snapped after the first bite.The surgeon opened a new package to close the sternum.There were no adverse patient consequences reported.No additional information was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 1/10/2019.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: an unopened sample of product code m653, lot mjh655 were returned for analysis.The product code is multi-strand and contains four strands per packet.During the visual inspection of an unopened samples, no defects were found on the package.The sample was opened the packet contains four strands, 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, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.

• Brand Name: STLESS STEEL SIL 4X18IN 5 S/A CCS
• 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: 8170268
• Report Number: 2210968-2018-77815
• Device Sequence Number: 11199319
• Product Code: GAQ
• UDI-Device Identifier: 10705031045477
• UDI-Public: 10705031045477
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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: 07/31/2023
• Device Catalogue Number: M653G
• Device Lot Number: MJH655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1