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

Catalog Number	K891H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
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 an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, when tying off the suture, the thread kept breaking.User reports the product felt brittle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/09/2019.A manufacturing record evaluation was performed for the finished device batch meq247-k891h and no non-conformances were identified.It was received for analysis an empty opened overwrap, three labeled winding formers, a needle-suture piece and a suture piece of product code k891, lot meq247.During the visual inspection of the sample, the swage and attachment area were noted to be as expected and the sutures pieces were observed detached due the stress applied to the strands, present damaged on the surface and stress at the ends.Additionally, a functional test was performed, the tensile pull and tensile force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition, it could not be determined what may have caused the reported incident of: ¿when tying off the suture the thread kept breaking¿.

• 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: 8668601
• Report Number: 2210968-2019-82378
• Device Sequence Number: 2292899
• Product Code: GAP
• UDI-Device Identifier: 10705031044722
• UDI-Public: 10705031044722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/08/2019

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: 04/30/2023
• Device Catalogue Number: K891H
• Device Lot Number: MEQ247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/09/2019
• Patient Sequence Number: 1