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

Catalog Number	M8702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(6).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 device analysis: the product was returned to ethicon for evaluation.The functional testing was conducted on the returned devices.The returned samples determined that it was received, one opened sample that pertained to product code m8702.Also, it was returned four tyvek with different lot numbers (tbbblb, slbamm, taberp).This product code is multi-strand and requires four strands double armed per packet.In order to evaluate the condition of the returned sample, three strands double armed were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.In addition, t could not be determined which lot the returned sample belongs to.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 tbbblb, m870256 and no non-conformances were identified.Mfg.Date feb/6/2023.Exp.Date jan/31/2028.A manufacturing record evaluation was performed for the finished device batch slbamm, m870256 and no non-conformances were identified.Mfg.Date - oct/4/2022.Exp.Date - sep/30/2027.A manufacturing record evaluation was performed for the finished device batch taberp, m870256 and no non-conformances were identified.Mfg.Date - jan/27/2023.Exp.Date - dec/31/2027.Events reported via: 2210968-2023-05885.
Event or Problem Description
It was reported that a patient underwent a anastomosis procedure in 2023 and suture was used.During the procedure, the surgeon was completing the anastomosis and going to tie the suture together at the end of the suturing, the suture broke.He grabbed a second suture to use a reinforcement stitch and that one broke as well.Opened a new lot number and the suture worked to finish the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17547316
• Report Number: 2210968-2023-05884
• Device Sequence Number: 12461696
• Product Code: GAW
• UDI-Device Identifier: 10705031045774
• UDI-Public: 10705031045774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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 Catalogue Number: M8702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown