MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 4-0 S/A PS-5 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z594G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Evaluation: a dispensed needle-suture of product was returned for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected and marks on the body and tip needle that appear to be by use of a surgical instrument could be observed and a section of the needle tip was missing due to was broken.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the condition of the sample received, the assignable cause of the performance surface related defect ¿ needle was suggest an improper handling and the reported complaint by an external cause.To condition of needle breakage an additional evaluation is necessary to determine the failure mode and the sample will be forwarded for further analysis.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown dermatologic surgery on (b)(6) 2018 and suture was used.The surgeon felt something unusual on the needle tip during the first passing of the needle through the tissue.Another needle-suture was used for the patient.No devices were left in the patient.The lot number is unknown.Further details are not provided there were no adverse consequences to the patient.Upon evaluation of the sample, it was noted the needle tip was broken.
Additional Manufacturer Narrative
(b)(4).A failed suture needle was submitted for fractographic evaluation.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) 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 composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The manufacturing records couldn¿t be reviewed as the batch number is unknown.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: PDSII UD 18IN 4-0 S/A PS-5 PRM MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8253516
• Report Number: 2210968-2019-78442
• Device Sequence Number: 1583185
• Product Code: NEW
• UDI-Device Identifier: 10705031061477
• UDI-Public: 10705031061477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/24/2018

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 Catalogue Number: Z594G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/04/2019
• Patient Sequence Number: 1