MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	C012D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
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.
Event or Problem Description
It was reported that a patient underwent a toe amputation on (b)(6) 2018 and suture was used.During the procedure, the suture was breaking in the middle of the strand while tying knots.A second like suture was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: unopened samples were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of the representative samples, no defects were found on the package.The samples were opened and the swage and attachment area were as expected.The sutures were examined along of strand and no defects or breakage suture were noted.Functional test was performed on the samples and the tensile force met the requirements.Per the condition of the representative samples, no suture breakage was noted.

• Brand Name: SILK SUTURE 18"(45CM) 2-0 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: 7638356
• Report Number: 2210968-2018-73822
• Device Sequence Number: 2324295
• Product Code: GAP
• UDI-Device Identifier: 10705031023390
• UDI-Public: 10705031023390
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 01/31/2023
• Device Catalogue Number: C012D
• Device Lot Number: MBH264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1