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

Catalog Number	K952H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown dental and oral surgery on an unknown date and suture was used.The suture was detached from the needle during use.The lot number is llh877.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.A labeled winding former with a partially dispensed suture and a detached needle were returned for analysis.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 slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.The dispensed suture was examined along of the strand and no defects were observed.However, the end of the suture was cut appears to be by the use of a surgical instrument.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.

• 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 0151
• MDR Report Key: 7797108
• Report Number: 2210968-2018-75267
• Device Sequence Number: 16443454
• Product Code: GAP
• UDI-Device Identifier: 10705031044760
• UDI-Public: 10705031044760
• 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): 07/24/2018

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: 09/30/2022
• Device Catalogue Number: K952H
• Device Lot Number: LLH877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1