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	Foreign Body In Patient (2687)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.This medwatch report is in response to receipt of maude event report #mw5080384.Additional information was requested and the following was obtained: what measures were taken to retrieve the broken piece? the surgeon attempted to remove the broken needle tip with his instruments but was unable to do so.Was there any additional tissue damage as a result of searching for the needle piece? no additional tissue damage noted.Were x-rays taken to locate the needle piece(s)? x-ray confirmed the needle tip in in the sternum.At what location was the needle found? the patient¿s sternum.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? no.If retained, what is the surgeon's opinion of consequences to the patient? the patient cannot have an mri in the future.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft procedure on (b)(6) 2018, and suture was used.During closure of the patient¿s chest the needle broke off in the patient¿s sternum.Attempts to retrieve the fragment were unsuccessful.No patient consequence was reported.

• 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: 8116199
• Report Number: 2210968-2018-77398
• Device Sequence Number: 1692748
• Product Code: GAQ
• UDI-Device Identifier: 10705031045477
• UDI-Public: 10705031045477
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 07/31/2019
• Device Catalogue Number: M653G
• Device Lot Number: JBH701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1