MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 7-0 D/A BV175-6 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8737
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: what was being done when the needle pulled-off (in the package/ removal from package / during passage through tissue)? suturing.What was the size of the needle used? bv-175.What tissue/location was suturing when pull off occurred? unknown.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no known adverse events.Lot number? rbbcs.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.Component code: (b)(4) device not returned.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2021 and suture was used.The needle popped off the suture.Another like device was used to complete the procedure.There were no adverse consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/14/2021.H6 component code: g07002 no device problem found.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.H3 evaluation: h3 investigation summary: one packet of product code m8737 was returned for analysis with the packaging closed.Upon initial inspection to the sample no external damages were observed on the packet.In order to evaluate the conditions of the returned sample, the packet was opened, and no defects were detected.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand to detect any issue related no defects were observed during evaluation.Functional test was performed, and the pull force meet requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch rbbcss, and no non-conformances were identified.

• Brand Name: PRLNE BLU 2X24IN 7-0 D/A BV175-6 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12012842
• Report Number: 2210968-2021-05626
• Device Sequence Number: 844676
• Product Code: GAW
• UDI-Device Identifier: 10705031046016
• UDI-Public: 10705031046016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 05/24/2021

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 Expiration Date: 01/31/2026
• Device Model Number: M8737
• Device Catalogue Number: M8737
• Device Lot Number: RBBCSS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1