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

Model Number	K952H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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: what was the name of the procedure? dentistry.What was being done when the needle pulled-off (in the package/ removal from package / during passage through tissue)? during use on patient.Were x-rays taken to locate the needle? unk.Was the needle piece removed from the patient during the same procedure? yes.Was there any patient consequence or injury?no.What is the condition of the patient? no consequence.
Event or Problem Description
It was reported that the patient underwent an unknown dental procedure in 2020 and suture was used.The needle wire detached from the suture during use.The needle was removed from the patient during the same procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 04/06/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

• 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: 9683627
• Report Number: 2210968-2020-01034
• Device Sequence Number: 10888048
• Product Code: GAP
• UDI-Device Identifier: 10705031044760
• UDI-Public: 10705031044760
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 09/30/2023
• Device Model Number: K952H
• Device Catalogue Number: K952H
• Device Lot Number: MLA099
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1