MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 6-0 S/A PC-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8636G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2024 and suture was used.There was a suture breakage upon dr tying the suture and pulling with light force.Dr also opines that the suture feels weaker.Additional information was requested.
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.H6 component code: g07002 device not returned a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been 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.Additional information was requested, and the following was obtained: was surgery delayed due to the reported event? --> no, was procedure successfully completed? --> yes, were fragments generated? --> no, patient status/ outcome / consequences --> no 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.* did the suture break during other procedures? if yes, please confirm the number of sutures affected per procedure.* have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/6/2024.Additional information was requested, the following was obtained: did the suture break during other procedures? if yes, please confirm the number of sutures affected per procedure.Not that i could trace.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Na.If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).Na.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) will check with clinic is able to provide details.Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.Product has been discarded.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 18IN 6-0 S/A PC-3 PRM 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: 19713816
• Report Number: 2210968-2024-07091
• Device Sequence Number: 8777855
• Product Code: GAW
• UDI-Device Identifier: 10705031018228
• UDI-Public: (01)10705031018228(11)230914(17)280831(10)TKBCSX
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 8636G
• Device Lot Number: TKBCSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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