MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K872H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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.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.Confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one event report/procedure? if 2 sutures involved, confirm if they are from same lot reported? it is stated in event, "risk of loss a needle in the operating site", confirm, did the needle fall into patient? if yes was it removed? if not, does any needle remain in the patient¿s tissue? and what tissue structure is it located? or did the needle fall outside patient body in operation/or field? if yes, was the needle found? patient current condition? note: events reported via medwatch 2210968-2019-82714.
Event or Problem Description
It was reported that the patient underwent cerebral tumerectomy on (b)(6) 2019 and suture was used.During the procedure the suture pulled off immediately during the suture of the dura mater.A like device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8696527
• Report Number: 2210968-2019-82715
• Device Sequence Number: 1888823
• Product Code: GAP
• UDI-Device Identifier: 10705031044586
• UDI-Public: 10705031044586
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/16/2019

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: K872H
• Device Lot Number: MLA247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1
• Patient Age: 5 YR