MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 60"(150CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP990G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was 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.1.What measures were taken to retrieve the broken piece? 2.Was there any additional tissue damage as a result of searching for the needle piece? 3.Were x-rays taken to locate the needle piece(s)? 4.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure?.
Event or Problem Description
It was reported that a patient underwent a wound closure on (b)(6) 2018 and suture was used.During the procedure, while closing fascia, the one-quarter end of the needle closest to the suture broke in two while the doctor was using the suture in the standard designed manner, utilizing a needle driver.A broken portion of the needle fell into the patient's abdominal cavity but was fully retrieved by the doctor.All pieces of the suture needle were removed and accounted for.It was not reported how the procedure was completed.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).The actual device was returned for evaluation.Upon evaluation, a fracture was observed in the body 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 predominately composed of microvoid coalescence, which is evidence of a ductile overload failure.Although evidence of a brittle failure was observed in the form of small areas of transgranular cleavage; mechanical damage and a cup-and-cone shaped fracture observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional information was requested and the following was obtained: 1.What measures were taken to retrieve the broken piece? needle was found easily.2.Was there any additional tissue damage as a result of searching for the needle piece? no.3.Were x-rays taken to locate the needle piece(s)? no.4.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? no.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.

• Brand Name: PDS PLUS SUTURE 60"(150CM) 0 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: 7282236
• Report Number: 2210968-2018-70930
• Device Sequence Number: 135721
• Product Code: NEW
• UDI-Device Identifier: 10705031048713
• UDI-Public: 10705031048713
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2018

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 Expiration Date: 07/31/2019
• Device Catalogue Number: PDP990G
• Device Lot Number: LJ6470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 03/23/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 02/23/2018; 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1