MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	A184H
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
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.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.Did the suture break intra-op or suture breakage noticed post-op? how was the post-op bleeding managed? was any medical/surgical intervention provided to patient post-op? was there any patient adverse event as outcome as a result of the event report? patient current condition?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture was used to ligate vessels.It was reported that the tie was broken and possible post operative bleeding occurred.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Investigation summary: an opened box with twelve unopened sample of product code a184 lot # lck351 were returned for analysis.The complaint sample was not received.During the visual inspection of the samples, no defects were found on the package.The sample was opened, and each packet contains twelve strands.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage was noted.A functional test was performed and the tensile strength force was above the minimum requirement.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 sample, no breakage suture post op was found and the tested sample met the finished goods requirements.Investigation summary: 5 unopened samples of product code a184h, lot # kek089, were returned for analysis.The complaint sample was not received.During the visual inspection of the samples, no defects were found on the package.The sample was opened, and each packet contains twelve strands.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage was noted.A functional test was performed and the tensile strength force was above the minimum requirement.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 sample, no breakage suture post op was found and the tested sample met the finished goods requirements.An unopened sample of product code a184h, lot # jjk552 was returned for analysis.The complaint sample was not received.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the packet contains twelve strands.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage was noted.A functional test was performed and the tensile strength force was above the minimum requirement.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 sample, no breakage suture post op was found and the tested sample met the finished goods requirements.

• Brand Name: SILK SUTURE 18"(45CM) 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: 8415157
• Report Number: 2210968-2019-79425
• Device Sequence Number: 11319744
• Product Code: GAP
• UDI-Device Identifier: 10705031023000
• UDI-Public: 10705031023000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/18/2019

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: No Information
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: A184H
• Device Lot Number: LCK351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1