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

Model Number	M653G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
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 the later date a supplemental medwatch will be sent.Two needle breakages occurred in same procedure were submitted via 2210968-2020-02528 and 2210968-2020-02529.
Event or Problem Description
It was reported that the patient underwent a post-operational sternal wound closure procedure after aortic valve replacement on (b)(6) 2020 and the suture was used for closing sternal points.It was reported that the tip of needle broke.The cavity was searched for the tip and it was not found.X-ray was performed and there was no evidence of needle tip inside of the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/30/2020.Corrected information: d3,g1,g2.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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
• MDR Report Key: 9914499
• Report Number: 2210968-2020-02529
• Device Sequence Number: 2416369
• Product Code: GAQ
• UDI-Device Identifier: 10705031045477
• UDI-Public: 10705031045477
• 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,Followup
• Report Date (Section B): 03/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: M653G
• Device Catalogue Number: M653G
• Device Lot Number: AM3019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/30/2020
• Patient Sequence Number: 1
• Patient Age: 56 YR