MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y317H
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
(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.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.Was the procedure extended by 60 minutes? if yes, please explain the reason for the prolonged surgery and if it had to do with the needle breakage.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery?.
Event or Problem Description
It was reported that a patient underwent a laparoscopic sacrocolpopexy on an unknown date and suture was used.During the procedure, the needle was broken at the swage part during use on the uterine cervix.The needle fragment was not lost and was retrieved.No devices were left in the patient¿s body.The operation time was extended by 60 minutes.The patient was discharged from the hospital with no problem.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/23/2019.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance needle breakage.A failed suture needle was submitted for fractographic evaluation.A fracture was observed at suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/2/2019.Additional information was requested and the following was obtained: was the procedure extended by 60 minutes? yes.If yes, please explain the reason for the prolonged surgery and if it had to do with the needle breakage.No information.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? no information.No further information will be provided.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8133137
• Report Number: 2210968-2018-77526
• Device Sequence Number: 16664398
• Product Code: GAN
• UDI-Device Identifier: 10705031058767
• UDI-Public: 10705031058767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• 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): 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: 12/31/2022
• Device Catalogue Number: Y317H
• Device Lot Number: MAM874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 01/04/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/02/2019; 01/23/2019
• Patient Sequence Number: 1