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

Model Number	C584D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).  attempts are being 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 neurosurgery on (b)(6) 2020 and the suture was used.During use, for dura mater lifting, the needle was broken at the tip.The lot number is unknown.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/18/2021.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, 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 information: additional h3 investigation summary: a suture needle was received for evaluation.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined 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 to determine the fracture mode.The evaluation of pc-000821461 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.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.

• Brand Name: NUROLON SUTURE 18"(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11113668
• Report Number: 2210968-2021-00018
• Device Sequence Number: 4051304
• 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): 12/10/2020

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: No Information
• Device Model Number: C584D
• Device Catalogue Number: C584D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/18/2021
• Patient Sequence Number: 1