MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 60IN 1 S/A TP-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8824G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a ablation procedure on (b)(6) 2022 and suture was used.On (b)(6) 2022 the patient returned to the or for a wound that dehisced.The doctor did look more closely at the suture and his knots were intact.No patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).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.Investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.One opened box with seven packets of product code 8824g was returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.Visual inspection of the unopened samples, no defects were found on the packets.The seven samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage, or suture breakage were noted.In addition, the prolene suture is not an absorbed product.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: the product seemed to break unexpectable after patients surgery.Additional information was requested, and no answer was obtained.If any additional information is received, a supplemental medwatch report will be sent.
Event or Problem Description
It was reported that a patient underwent a ablation procedure on (b)(6) 2022 and suture was used.On 02/22/2022 the patient returned to the or for a wound that dehisced.The doctor did look more closely at the suture and his knots were intact.Additional information was requested.

• Brand Name: PRLNE BLU 60IN 1 S/A TP-1
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14760907
• Report Number: 2210968-2022-04732
• Device Sequence Number: 1294381
• Product Code: GAW
• UDI-Device Identifier: 10705031020887
• UDI-Public: 10705031020887
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/24/2022

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 Expiration Date: 06/30/2026
• Device Model Number: 8824G
• Device Catalogue Number: 8824G
• Device Lot Number: RHBAHZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 06/24/2022
• Date Device Manufactured: 07/01/2021
• 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