MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV-1 VB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? 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 a coronary artery bypass graft procedure on (b)(6) 2021 and suture was used.The needle was broken during use, and no pieces were left inside the patient.The operation time was extended within 30 minutes.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/1/2021.H6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample (three strands double armed) of product code m8304 was received for evaluation, the product multistrand count and each packet contains four strands double armed.Visual inspection to six needles and the swage and attachment area were noted to be as expected.No breakage needle were noted.Also, the sample was tested by resistance test to needle and met the requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The following information was requested, but unavailable: lot number? attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? 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 Manufacturer Narrative
(b)(4).Date sent to the fda: 3/24/2021.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 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 information: h6.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code m8304 was received for evaluation, the product multistrand count and each packet contains four strands double armed.The evaluation conclude a needle of the strand double armed was broken at the swage part and due to condition of the broken needle, additional evaluation is necessary to determine the assignable cause.A failed suture needle was submitted for fractographic evaluation.The component was identified as product code m8304.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 revealed the fracture was 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.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 at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.The following information was requested, but unavailable: was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery?.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV-1 VB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11263954
• Report Number: 2210968-2021-00881
• Device Sequence Number: 1283934
• Product Code: GAW
• UDI-Device Identifier: 10705031045644
• UDI-Public: 10705031045644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2021

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: No Information
• Device Model Number: M8304
• Device Catalogue Number: M8304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/01/2021; 03/01/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/01/2021; 03/24/2021
• Patient Sequence Number: 1