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

Catalog Number	K834H
Medical Device Problem Code	Break (1069)
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.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.Please provide specific number of devices with suture breakage issue during use in the procedure.How was the case completed? has the product been returned yet? note: events reported in 2210968-2019-89605, and 2210968-2019-89606.
Event or Problem Description
It was reported that a patient underwent a plastic surgery procedure on an unknown date and suture was used.During the procedure, the suture kept snapping when tying off or suturing.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mah862, and no non-conformances were identified.

• Brand Name: SILK SUTURE 30"(75CM) 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: 9285663
• Report Number: 2210968-2019-89607
• Device Sequence Number: 1891719
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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 Expiration Date: 12/31/2022
• Device Catalogue Number: K834H
• Device Lot Number: MAH862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 11/11/2019
• Patient Sequence Number: 1