MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C003D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Attempts are being made to receive a device for evaluation.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.Additional information was requested, and the following was obtained: what is the specific number of devices (total qty involved) that failed during this procedure? the sales rep reported 6 devices.Status of product return: the device has been received and will be shipped.Please check rmao.No further information will be provided.6 reported device events were submitted via medwatches: 2210968-2020-01636, 2210968-2020-01638, 2210968-2020-01639, 2210968-2020-01640 and 2210968-2020-01641.
Event or Problem Description
It was reported the patient underwent an unknown urological procedure on (b)(6) 2020 and the suture was used.It was reported that when opening the package, it was found that the suture had been detached from the needle.It was a control release needle.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/02/2020.A manufacturing record evaluation was performed for the finished device lot pcb278, and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an empty opened overwrap, a paper lid and a winding former with a detached needle and five undispensed needles-sutures of product code c003d, lot pcb278.The product code is control release and requires of eight strands per packet.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.In addition, the suture that failed was not received.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: SILK SUTURE 18"(45CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9774480
• Report Number: 2210968-2020-01637
• Device Sequence Number: 3086846
• Product Code: GAP
• UDI-Device Identifier: 10705031023345
• UDI-Public: 10705031023345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: C003D
• Device Catalogue Number: C003D
• Device Lot Number: PCB278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1