MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 24IN(60CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8860H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in 2210968-2020-10153 and 2210968-2020-10154.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.Additional information was requested, and the following information was obtained: were the needles removed from the patient during the same procedure? have no idea what this question means.We did not lose a needle.What tissue/location was suturing when pull off occurred? the suture broke well before the swedge.(b)(6) likes to use 5-0 prolene bb as a subcuticular closure were there any unexpected outcomes or complications as a result of this suture needle pull off event? no.Procedure date? (b)(6) 2020.We had another incident last week.Do not know the surgical date.Again it was being used as a subq closure.The needle popped off at swedge twice.That box was taken out of circulation too.(b)(6), " i will give you both boxes." 5-0 8860h bb both lot numbers are pmr704.(b)(6) was the pa on both cases.(b)(6) the surgeon.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2020, and a suture was used.During the procedure, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/28/2021.Additional information was requested and the following was obtained: contacted sales rep via telephone to request additional information regarding "another incident".The sales rep informed me that she had attempted to contact customer ((b)(6)) on 1/22 and 1/26 however she was unable to get a response regarding additional events.She also spoke with (b)(6) at the hospital who also didn¿t have any further information.Sales rep indicates customer may have been confused and was referencing the same event/ products as initially reported and that we should keep only as 1 complaint at this time.No additional information is available at this time.If additional information is provided additional files will be opened accordingly.
Additional Manufacturer Narrative
Date sent to the fda: 01/22/2021.H6 component code: g07002 ¿ conforming device.A manufacturing record evaluation was performed for the finished device batch pmr704 and no non-conformances were identified.Additional h-3 summary: it was received for evaluation an opened box with thirty-three unopened samples of product code 8860h, lot pmr704.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted and the actual complaint sample was not returned for analysis.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.Corrected b5 narrative: it was reported that a patient underwent a cabg procedure on (b)(6) 2020 and a suture was used for subcuticular closure.During the procedure, the suture pulled off the needle; " suture broke well before the swedge".Another like device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: PROLENE SUT 24IN(60CM) 5-0 BLU
• 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: 11051724
• Report Number: 2210968-2020-10155
• Device Sequence Number: 19146649
• Product Code: GAW
• UDI-Device Identifier: 10705031021372
• UDI-Public: 10705031021372
• 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,Followup,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 10/31/2024
• Device Model Number: 8860H
• Device Catalogue Number: 8860H
• Device Lot Number: PMR704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/18/2021; 01/22/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/22/2021; 01/28/2021
• Patient Sequence Number: 1