MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 3-0 D/A TE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D9749
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.When was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)?: please specify.Please provide the lot number: please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Attempts are being made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2023 and suture was used.The suture was easily detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/13/2023 additional information: d9, h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that seven needle-suture pieces, one detached needle, and one suture piece outside of one straight folder packet that pertained to product code d9749 were returned for analysis.This product code is multistrand and required four strands double armed per packet.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, the short insertion issue was identified as pull out 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.Additional information was requested, the following was obtained: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.It occurred probably during removal from package.Please provide the lot number: unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sales rep about the device returning.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).(b)(6).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 4X30IN 3-0 D/A TE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16964465
• Report Number: 2210968-2023-03702
• Device Sequence Number: 5238438
• Product Code: GAW
• UDI-Device Identifier: 10705031034587
• UDI-Public: 10705031034587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2023

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 Model Number: D9749
• Device Catalogue Number: D9749
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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