MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X36IN 4-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8557
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information provided: they opened 3 different packages.They did not retain any of the broken sutures.They would like to send in the sterile samples for testing.They would like a replacement box was there any reported patient or user harm? no.Was there a significant delay? no.If available, provide the product order number (po).Please provide replacement product and ship to (b)(6) at the account address.Do you need product packaging to send the product back? yes.This parcel contains biohazardous materials and/or materials used during a medical procedure.No.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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, 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.
Event or Problem Description
It was reported that during a cardio vascular procedure on (b)(6) 2026 and suture was used.The suture broke while suturing.They did not retain any of the broken sutures.No delay or patient harm was reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 type of investigation: b21 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information: h6, d9.
Additional Manufacturer Narrative
Product complaint # (b)(4.) corrected information: d 4.Primary udi number, d 9.Device available for evaluation?, h 3.Device evaluated by manufacturer? additional information: d 4.Expiration date, d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 3.Device evaluated by manufacturer?, h 4.Device manufacture date, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - no device problem found.H3 investigation summary : the product was returned to ethicon for evaluation.One open box with nine representative unopened samples was received for analysis.Product code m8557.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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, 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.

• Brand Name: PRLNE BLU 4X36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24590182
• Report Number: 2210968-2026-02524
• Device Sequence Number: 12995026
• Product Code: GAW
• UDI-Device Identifier: 10705031045736
• UDI-Public: (01)10705031045736(17)UCMJTH(10)47177
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: M8557
• Device Lot Number: UCMJTH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/11/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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