MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8711H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Analysis summary: a failed suture needle was received for fractographic evaluation.The component was identified as product code ep8711h.A fracture was observed on both ends 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 needles.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fractures were 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.These were ductile fractures.Unintended use error caused or contributed to event.A manufacturing record evaluation was performed for the finished device batch qlbecp, ep8711h56 and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2021 and suture was used.It was noted prior to use that the needle was "burred¿.No fragments were generated and there was no delay in surgery.The procedure was completed successfully and there were no patient consequences., he spotted before using it.No further event information was provided.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11752615
• Report Number: 2210968-2021-04097
• Device Sequence Number: 14495089
• Product Code: GAW
• UDI-Device Identifier: 10705031231313
• UDI-Public: 10705031231313
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 09/30/2025
• Device Model Number: EP8711H
• Device Catalogue Number: EP8711H
• Device Lot Number: QLBECP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1