MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN USP4-0; SUTURE, NONABSORBABLE, SILK

Catalog Number	K942H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported needle pull off.An empty opened overwrap, a paper lid, a winding former, a detached needle, a suture piece and six unopened samples of product code k942, lot # lgp500 were returned for analysis.During the visual inspection of needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under 20x magnification and remnant suture were noted.The suture end is severely cut (damaged), resulting in a clip off defect.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of sample received, the assignable cause of the needle pull off suggests a clip off defect.In the visual inspection of six unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area were as expected.However, chipping defect was noted; since, suture is swaged excessively at the end of a channel/barrel causing some degree of suture damage.The suture was dispensed without problems and examined along of the strand and no defects were observed.Functional test was performed on the samples and the pull force met the requirements.Per the condition of the six representatives samples, the assignable cause of the needle pull off was caused by chipping defect.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on 06/27/2018 and suture was used.During the procedure, the needle pulled off from the thread, tearing the mucous membrane.No medical or surgical intervention was necessary.There were no adverse patient consequences reported.

• Brand Name: SILK BLK 30IN USP4-0
• 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: 8133214
• Report Number: 2210968-2018-77524
• Device Sequence Number: 138254
• Product Code: GAP
• UDI-Device Identifier: 10705031100770
• UDI-Public: 10705031100770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/09/2018

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: 05/31/2022
• Device Catalogue Number: K942H
• Device Lot Number: LGP500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1