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)
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 the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on unknown date and the suture was used.During procedure, 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: 2/24/2020.Additional h3 investigation summary: it was reported pull off - suture needle.One open sample of product code c003 was received for analysis.The product code is control release and required eight strands single armed per packet.During visual inspection of the winding former, the needle of slot #1 was separate.The swage and attachment area were noted to be as expected and the barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The suture was dispensed and examined, the insertion end was observed to be as expected.In addition, seven needle-suture combination were visually inspected and the swage and attachment area were noted to be as expected.The sutures were dispensed and examined along of the strand, no defects or damaged were found.The functional test was performed and the pull force results meet the customer requirements.The manufacturing records could not be reviewed as the batch number is unknown.Due to condition of the detached needle, it could not be determined what may have caused the reported incident of: ¿ it was found that the suture had been detached from the needle.It was a control release needle¿.

• 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: 9584518
• Report Number: 2210968-2020-00337
• Device Sequence Number: 458112
• 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): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C003D
• Device Catalogue Number: C003D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention