MAUDE Adverse Event Report: ETHICON INC. PDS SUTURE 18"(45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number D8252

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.

Event Description

It was reported that a patient underwent a plastic surgery procedure on (b)(6) 2018, and suture was used.The needle was easily bent and broken at the tip during dermostitch.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/16/2019.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Manufacturer Narrative

(b)(4).Date sent to the fda: 02/27/2019.Investigation summary: it was reported performance needle breakage.A failed suture needle was submitted for fractographic evaluation.A fracture was observed at the tip of sample a.Sample a 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 needles.The fracture surface was 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.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 at the tip 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 SUTURE 18"(45CM) 4-0 VIO
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8196783
• MDR Text Key: 131423832
• Report Number: 2210968-2018-78027
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031029644
• UDI-Public: 10705031029644
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: D8252
• Device Lot Number: MHK384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 02/05/2019
• Supplement Dates FDA Received: 01/16/2019; 02/27/2019
• Patient Sequence Number: 1