MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	K881H
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).Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.During the procedure, the suture pulled off the needle.It was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/19/2020.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/02/2020.A manufacturing record evaluation was performed for the finished device batch pcj760 and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an empty opened overwrap, an empty labeled winding former, a detached needle and four sutures pieces of product code k881h, lot pcj760.During the visual inspection of the needle, the swage and attachment area were as expected, and remnant of the suture was noted into the barrel hole and marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.In addition, the ends of the suture pieces were cut appears to be by use of the surgical instrument.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance - pull off suture needle is an improper handling.

• Brand Name: SILK SUTURE 30"(75CM) 4-0 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: 10005306
• Report Number: 2210968-2020-03572
• Device Sequence Number: 3406572
• Product Code: GAP
• UDI-Device Identifier: 10705031044647
• UDI-Public: 10705031044647
• 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,Followup
• Report Date (Section B): 04/23/2020

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: K881H
• Device Catalogue Number: K881H
• Device Lot Number: PCJ760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 05/29/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/02/2020
• Patient Sequence Number: 1