MAUDE Adverse Event Report: ETHICON INC. PDS+ U 45 CM M1.5 PS-4 MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	PDP509G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that a patient underwent an unknown ob-gyn procedure on an unknown date and the suture was used.It was reported that during surgery, the surgeon held the needle with a needle-holder, the needle was broken easily at the swage part though no extra force was applied.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Date sent to the fda: 03/05/2020.H3 evaluation: a failed suture needle was submitted for fractographic evaluation to assess the fracture mode of the failure.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 examined for this evaluation.A microscope 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 of the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, 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 manufacturing records could not be reviewed as the batch number is unknown.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and over-stressing of the needle.  there is no evidence of any material flaw that would cause premature failure.The needle breakage was observed.

• Brand Name: PDS+ U 45 CM M1.5 PS-4 MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9708982
• Report Number: 2210968-2020-01178
• Device Sequence Number: 3319808
• Product Code: NEW
• UDI-Device Identifier: 10705031207240
• UDI-Public: 10705031207240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 01/20/2020

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: PDP509G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1