MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K832H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 an unknown surgery on (b)(6) 2018 and suture was used.The suture was broken when tying a knot with an instrument.The surgeon commented that he tied with usual force.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it was reported: suture breakage.Ten unopened samples of product code k832, lot # lej461 were returned for analysis.The issue sample was not received for analysis.During the visual inspection of ten unopened samples, no defects were observed on the packets.The samples were opened and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damage was noted.A functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no suture breakage was observed and the tested sample meet the finished goods requirements.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 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: 8231746
• Report Number: 2210968-2019-78292
• Device Sequence Number: 16420672
• Product Code: GAP
• UDI-Device Identifier: 10705031044364
• UDI-Public: 10705031044364
• 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,Followup
• Report Date (Section B): 12/13/2018

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: 04/30/2022
• Device Catalogue Number: K832H
• Device Lot Number: LEJ461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 01/30/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 01/29/2019; 02/26/2019
• Patient Sequence Number: 1