MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN USP4-0; SUTURE, NONABSORBABLE, SILK

Catalog Number	K942H
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.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.Additional information was requested and the following was obtained: what instruments were used to grasp the needle?unk.Where was the needle grasped during use?unk.What are the patients age, weight, bmi, other medical conditions?unk.Were x-rays performed to determine the location of the needle? no.Is the needle retained in the patient? unk.If retained, what tissue is the needle located in? will the device be returned for evaluation? unk.What is physician¿s opinion as to the etiology of or contributing factors to this event? unk.What is the patient¿s current status? no event on patient at the moment.
Event or Problem Description
It was reported that a patient underwent a dental procedure on (b)(6) 2019 and suture was used.When the surgeon was completing the suture, after the extraction of the molar, the needle detached from the suture.The suture was fraying at the point of insertion of the thread on the needle.The surgeon searched for the needle piece and could not locate it.He examined controlled at oral, pharyngeal level and subsequently in suction filters.The patient had no kind of annoyance, but it is not possible to exclude that he could accidentally swallowed it.The patient current status reported as no event on patient at the moment.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what is the patient¿s current status? he is fine.

• Brand Name: SILK BLK 30IN USP4-0
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9298163
• Report Number: 2210968-2019-89749
• Device Sequence Number: 19542307
• Product Code: GAP
• UDI-Device Identifier: 10705031100770
• UDI-Public: 10705031100770
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: K942H
• Device Lot Number: MKQ220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention