MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
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.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.The possible lot provided mek711 correspondis to a different product code pdp925.Can you clarify the lot number of the device used as reported product code z347?.
Event or Problem Description
It was reported that the patient underwent a whipple procedure on (b)(6) 2019 and suture was used.The suture broke from the needle near the swage.The hospital staff opined that very gentle pressure is used during these cases with the needle holder so it is not thought to have been caused during the needle arming process.The procedure was completed successfully with no delay in the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 4/29/2019.Additional information : concomitant medical products and device evaluated by mfr.Additional evaluation summary: an empty opened foil and a folder with a detached needle and a undispensed suture of product code z347, lot mek771 were returned for analysis.During the inspection visual of the sample, the suture was dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the tensile strength force was above the minimum requirement.In addition, the needle was examined, and the swage and attachment area were not as expected; since the needle was split and broken on the swage area.This condition causes that not central to the needle thread.Needle crack barrel defect was observed.A fracture was observed at the suture attachment of the needle.The needle exhibited amounts of intergranular failure., which is evidence of a brittle failure.This was a non-ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 information was requested and the following was obtained: the possible lot provided mek711 corresponds to a different product code pdp925.Can you clarify the lot number of the device used as reported product code z347? not able to confirm the correct device code.The product had already been shipped for evaluation.Details can be confirmed on receipt of the device at the analysis site.

• Brand Name: PDS II SUTURE 36"(90CM) 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: 8379797
• Report Number: 2210968-2019-79163
• Device Sequence Number: 11494555
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: 10705031060685
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 02/05/2019

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: 04/30/2023
• Device Catalogue Number: Z347H
• Device Lot Number: MEK771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/06/2019; 02/05/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/01/2019; 04/29/2019
• Patient Sequence Number: 1