MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8557H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.- how many devices demonstrated the alleged deficiency? - did the event occur during one or multiple patient procedures? - what is the total number of procedures? - have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? - if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? additional information received; i¿m not sure about this information ¿ but i¿ve had trouble with the 4-0 rb1 suture needles bending, breaking and or becoming dull.This has been happening despite being very careful to avoid handling the needle tip.This has been happening in my cases for the last while - i don¿t use it during cabg for anything other than oversewing cannulation sites, its during procedures that require extended suture lines (ie.On the aorta).This also happened in r¿s case i assisted on the other evening.I did email my colleagues to see if anyone else has had issues.
Event or Problem Description
It was reported an animal underwent an veterinary cabg procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported to the rep that during a cabg procedure that on an unknown number of sutures that the tip of the needles were bending easily but did not break.Another like device was used till the procedure was completed.There were no adverse consequences reported.No devices returning.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22514074
• Report Number: 2210968-2025-08166
• Device Sequence Number: 21182881
• Product Code: GAW
• UDI-Device Identifier: 10705031017061
• UDI-Public: (01)10705031017061(17)300131(10)106DDE
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/15/2025

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: 8557H
• Device Lot Number: 106DDE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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