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

Catalog Number	8776H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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.It was reported the needles tear off the suture.What is the total number of products involved in this event? a review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6: component code: g07002: device not returned.Related events captured via: 2210968-2024-02456.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024; and a suture was used.The needle tore off the suture.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint (b)(4) date sent to the fda: 5/24/2024 h6 component code: g07002 no device problem found h3 investigational summary: the product was returned to ethicon for evaluation.The returned product determined that it was received sixteen unopened that pertain to product code 8776h.After visually inspecting the returned samples, it was found that twelve samples had an incorrect swage.The marks in the swage area were not as expected, causing a pull off in two needle suture combinations.In the remaining four samples the swage and attachment area were noted as expected.Additionally, the suture was examined, and the insertion mark could be observed in the extremes of the sutures.A functional test was performed using instron equipment, and the pull force did not meet the minimum requirements on two samples.In the other fourteen samples, the pull force result was above the minimum requirements.Based on the information currently available, an incorrect swage was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be 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 6-0 D/A BV
• 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: 18841260
• Report Number: 2210968-2024-02457
• Device Sequence Number: 12566353
• Product Code: GAW
• UDI-Device Identifier: 10705031020481
• UDI-Public: 10705031020481
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 8776H
• Device Lot Number: TGBKPZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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