MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M654G
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 were met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle fragment? what is the patient current situation? does the surgeon plan on removing the needle piece from the patient? were there any unexpected outcomes or complications as a result of the retained needle? was the patient treatment altered in anyway due to the retained needle? if yes, please explain.
Event or Problem Description
It was reported that the patient underwent valve procedure on unknown date and suture was used to close the sternum.The tip of the needle broke and remains inside the patent¿s sternum.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: STLESS STEEL SIL 4X18IN 6 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: 7719570
• Report Number: 2210968-2018-74624
• Device Sequence Number: 1754014
• Product Code: GAQ
• UDI-Device Identifier: 10705031000063
• UDI-Public: 10705031000063
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 06/30/2018

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: 01/31/2023
• Device Catalogue Number: M654G
• Device Lot Number: AK2916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2018
• Initial Report FDA Received Date: 07/25/2018
• Patient Sequence Number: 1
• Patient Age: 63 YR