MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8807
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2024 and suture was used.During the procedure, the suture frayed.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.- were there any patient consequences? if yes, please describe.- when did the reported event happened (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? if other, please provide details.- please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).- please provide the name of procedure.
Additional Manufacturer Narrative
Product complaint (b)(4).H6 component code: g07002 - no device problem found.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, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.Twenty-six representative unopened samples and one unused open sample were received for analysis.Product code w8807.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples and the open sample.The packets were examined, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects or fraying suture were observed during evaluation.Also, a tactile test was performed with the affected parts of the thumb and forefinger and no anomalies were detected.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional information was requested and the following was obtained: were there any patient consequences? none reported.If yes, please describe.- when did the reported event happened (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? during surgery, during suture.Note body (local language).Aei received date 10/18/2024 8:40 am.

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC175-8 MP
• 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: 20446342
• Report Number: 2210968-2024-10747
• Device Sequence Number: 8091351
• Product Code: GAW
• UDI-Device Identifier: 10705031231719
• UDI-Public: (01)10705031231719(11)231020(17)280930(10)TLBHAH
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 11/13/2024

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: W8807
• Device Lot Number: TLBHAH
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown