MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 6-0 D/A G-6 PRM; SUTURE, NONABSORBABLE, SILK

Catalog Number	769G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.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.It was reported that ¿the type of surgical procedure was changed, using another device.¿ does this mean that there was an additional surgical procedure performed? was an additional surgical incision required? please explain.Was any medical/surgical intervention required because the needle broke during wound closure?.
Event or Problem Description
It was reported that a patient underwent a surgical procedure on (b)(6) 2018 and suture was used.The needle broke during during wound closure.The type of surgical procedure was changed, using another device.No patient consequence.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to fda: (b)(4) 2018.Additional information was requested and the following was obtained: does this mean that there was an additional surgical procedure performed? no, the thread has been changed and the procedure has been completed.Was an additional surgical incision required? no.Was any medical/surgical intervention required because the needle broke during wound closure? no.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported performance breakage needle.A failed suture needle was submitted for fractographic evaluation.A fracture was not observed on the needle; therefore, no further evaluation was performed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The evaluation revealed the needle was not fractured.An unopened sample was returned for analysis.During the visual inspection of thirteen samples, no defects were found on the package.The sample was opened and the swage and attachment area were as expected; also, the tip and body of the needle was examined under magnification and no defects, damage or needle breakage were found.Besides, the resistance test was performed and no issues or anomalies were noted.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the condition of the sample, no needle breakage was found.

• Brand Name: SILK BLK 18IN 6-0 D/A G-6 PRM
• 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: 7756744
• Report Number: 2210968-2018-74960
• Device Sequence Number: 19152666
• Product Code: GAP
• UDI-Device Identifier: 10705031010451
• UDI-Public: 10705031010451
• 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,Followup,Followup
• Report Date (Section B): 07/16/2018

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: 02/28/2023
• Device Catalogue Number: 769G
• Device Lot Number: MC6726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 11/08/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/11/2018; 12/04/2018
• Patient Sequence Number: 1