MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z341H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
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.A manufacturing record evaluation was performed for the finished device mg6496 number, and no non-conformances were identified.Second device reported under mw 2210968-2019-83534.
Event or Problem Description
It was reported that the patient underwent a laparoscopic cholecystectomy procedure on (b)(6) 2019 and suture was used.The needle broke when trying to close the tissue.Another device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/09/2019.H3 device evaluation summary: the device component was identified as product code z341h was received for evaluation.A fracture was observed in the body of sample a.The needle was received in two pieces, only one of the mating fracture surface was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needles.The fracture surface was examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fractures and macroscopic plastic deformation 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 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 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.Second device, sample b reported under mw 2210968-2019-83534.

• Brand Name: PDSII VIO 27IN 1 S/A CT-1
• 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: 8751066
• Report Number: 2210968-2019-83533
• Device Sequence Number: 1998961
• Product Code: NEW
• UDI-Device Identifier: 10705031060647
• UDI-Public: 10705031060647
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: N18331
• 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
• Report Date (Section B): 06/10/2019

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: 05/31/2013
• Device Catalogue Number: Z341H
• Device Lot Number: MG6496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1