MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 2-0 D/A ST-70; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8400
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture had been detached.It was 2 times in a row.It was not a control release needle.The operation time was extended within 30 minutes.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 ¿ type of investigation not yet determined.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? a manufacturing record evaluation was performed for the finished device lot, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/9/2024 h6 component code: g07002 no device problem found additional information: d4, d9, h3, h4, h6 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.The returned product determined that it was received, one open box with four unopened samples that pertained to the product code w8400.The product code is double armed.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: PRLNE BLU 30IN 2-0 D/A ST-70
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19715112
• Report Number: 2210968-2024-07097
• Device Sequence Number: 8605064
• Product Code: GAW
• UDI-Device Identifier: 10705031128019
• UDI-Public: (01)10705031128019(11)230710(17)280630(10)THBAJD
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: W8400
• Device Lot Number: THBAJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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