MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 1 NON NDL; SUTURE, NONABSORBABLE, SILK

Model Number	SA87G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot peiag, and no non-conformances were identified.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.Investigation summary: actual complaint sample can't be returned, batch records have been reviewed and no issue found.Manufacturer retained samples have been evaluated by appearance and knot pull tensile strength and no issue found.The root cause of complaint can't be determined.
Event or Problem Description
It was reported that a patient underwent a procedure for rectal cancer on (b)(6) 2019 and suture was used.During the procedure, the suture broke when sewing.Changed another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: SILK BLK 10X30IN 1 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9616006
• Report Number: 2210968-2020-00578
• Device Sequence Number: 13590011
• Product Code: GAP
• UDI-Device Identifier: 10705031050303
• UDI-Public: 10705031050303
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/31/2019

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: 04/30/2024
• Device Model Number: SA87G
• Device Catalogue Number: SA87G
• Device Lot Number: PEIAG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1