MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 60"(150CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D8020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 exploratory laparotomy procedure on (b)(6) 2018 and a suture was used.During surgery, the needle broke at the swage.No part of the needle fell into the patient, and all pieces were found.The procedure was completed with an alternate like device.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/21/2018.Investigation summary: it was reported performance needle breakage.The actual device was returned for evaluation.A fracture was observed at the 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.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The manufacturing records couldn't be reviewed as the batch number is unknown 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.

• Brand Name: PDS II SUTURE 60"(150CM) 1 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7966531
• Report Number: 2210968-2018-76524
• Device Sequence Number: 11150982
• Product Code: NEW
• UDI-Device Identifier: 10705031028999
• UDI-Public: 10705031028999
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Catalogue Number: D8020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/21/2018
• Patient Sequence Number: 1