MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A V-5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8935H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on 03/12/2024 and suture was used.During the procedure, suture fraying during procedure.While doing suture knots thread broke.Unreported repeated episodes regarding prolene.There were no adverse consequences reported.Additional information was requested.
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 procedures were affected? * how many devices demonstrated the alleged deficiency on each involved patient event? how many sutures frayed, and how many sutures broke? * were there any patient consequences? * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) * please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.
Additional Manufacturer Narrative
Product complaint # (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.Additional information: h6.Additional information was requested and the following was obtained: how many procedures were affected? can´t be precise on that.Like i said before, there were many unreported episodes by hcps.The ones involved, namely in cardiac surgery, say that as far as they remember, more than 5 procedures.How many devices demonstrated the alleged deficiency on each involved patient event? how many sutures frayed, and how many sutures broke? 2 to 3 devices per patient.Most of them frayed and if continued using, ultimately broke were there any patient consequences? no.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep dr.(b)(6).
Additional Manufacturer Narrative
Product complaint # (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.Additional h3 investigation summary: the product was returned to ethicon for evaluation.One needle-suture piece outside its packaging was returned for analysis.Product code 8935h.During the visual inspection of the sample, fraying suture were noted near of one extreme, the extreme of the suture was noted to be cut possibly caused by a surgical instrument.In addition, the other section of the suture was not returned for analysis.Per the condition of the returned sample, the functional test could not be performed.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.No conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 36IN 4-0 D/A V-5
• 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: 21027513
• Report Number: 2210968-2024-14077
• Device Sequence Number: 21093928
• Product Code: GAW
• UDI-Device Identifier: 10705031022089
• UDI-Public: (01)10705031022089(17)290430(10)100ZAZ
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup,Followup
• Report Date (Section B): 02/20/2025

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: 8935H
• Device Lot Number: 100ZAZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 01/23/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/06/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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