MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A408
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested and the following was obtained: did any piece of the needle fall inside of the patient? => no, it didn't.If so, was the needle piece removed and how? => n/a.No further information will be provided." 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.Can you confirm procedure was on (b)(6) as you noted alert (awareness date of jnj employee) is (b)(6), the day before the event?.
Event or Problem Description
It was reported that patient underwent a coronary artery bypass graft on (b)(6) 2018 and barbed suture was used.The suture detached from the needle while closing the fascia using continuous suturing.A different device was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: can you confirm procedure was on (b)(6) as you noted alert is (b)(6), the day before the event? we confirmed both alert date and procedure date are (b)(6).Device evaluation summary: the actual device was received for evaluation.During the visual inspection of sample, the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture piece (a) present damaged (slice, crushed) near of end until swage area and body fluids on this area, also the other end was cut that appears to be by the use of a surgical instrument.The suture piece (b) present body fluids and the end was cut that appears to be by the use of a surgical instrument.In addition, the ends of the suture pieces a and b do match.Per the sample condition of the received sample, the assignable cause of performance - pull off suture needle suggest an improper handling.

• Brand Name: SFX SYM PDS+ VIO 18IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7451400
• Report Number: 2210968-2018-72290
• Device Sequence Number: 107257
• Product Code: NEW
• UDI-Device Identifier: 10705031219335
• UDI-Public: 10705031219335
• Combination Product (Y/N): N
• PMA/510(K) Number: K113004
• 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): 04/02/2018

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 Catalogue Number: SXPP1A408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1