MAUDE Adverse Event Report: ETHICON INC. NUROLON SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	C584D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following information was obtained: how was the procedure completed? no further information is available.Procedure name? no further information is available.Could you please provide lot number? no further information is available.Device return status/follow up: we regularly contact with sales rep about the device returning.No further information will be provided.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) date sent to the fda: 4/22/2021 additional information: d9, h6 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: two failed suture needles were submitted for fractographic evaluation.The components were identified as product code c584d.It was requested to assess the fracture mode of the failures.A fracture was observed at the tip of sample a and in the body of sample b.The needles were received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needles.Sample a the fracture surfaces were examined in multiple locations in order to determine the fracture mode.Sample b 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.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.These were ductile fractures.The manufacturing records could not 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.Correction data: d3.

• Brand Name: NUROLON SUTURE 18"(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11339806
• Report Number: 2210968-2021-01522
• Device Sequence Number: 16405570
• Product Code: GAR
• UDI-Device Identifier: 10705031023987
• UDI-Public: 10705031023987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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 Model Number: C584D
• Device Catalogue Number: C584D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1