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

Catalog Number	Z333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2018
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.
Event or Problem Description
It was reported suture was used during a veterinarian procedure.The needle broke approximately 2 mm above the swage.
Additional Manufacturer Narrative
The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/08/2018 device evaluation summary: representative samples were returned for evaluation.The sample was opened and the swage and attachment area were as expected; also, the tip and body of the needle no defects or needle breakage was observed.They were visually and functionally examined for resistance needle strength and they met the requirements.Per the condition of the representative samples, no performance ¿ breakage needle were found on the samples and the tested sample met the requirements.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 microscopically examined for this evaluation.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.A cup-and-cone shaped fracture 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 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 27"(70CM) 2-0 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: 7413157
• Report Number: 2210968-2018-72047
• Device Sequence Number: 16418219
• Product Code: NEW
• UDI-Device Identifier: 10705031060548
• UDI-Public: 10705031060548
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2018

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: 05/31/2022
• Device Catalogue Number: Z333H
• Device Lot Number: LG6847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/04/2018; 05/02/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/27/2018; 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1