MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A RB-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8711H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 9/4/2024.H6 component code: g07002 - no device problem found this report is being submitted pursuant to the provisions of 21 cfr.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: 1.Please clarify if there were consequences for the patient no, there were no patient consequences.2.Status of product return product was sent out via fedex this week.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with twelve unopened samples was received for analysis for product code 8711h.This product 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The surgeon has had multiple sutures pop off the needle during surgery.The loading of the suture was looked at and it was being done properly, away from the swage.There were no patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 30IN 6-0 D/A RB-2
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20135380
• Report Number: 2210968-2024-09270
• Device Sequence Number: 7287534
• Product Code: GAW
• UDI-Device Identifier: 10705031019560
• UDI-Public: (01)10705031019560(17)281231(10)UABJMS
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 8711H
• Device Lot Number: UABJMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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