MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2023 and suture was used.During the procedure, the needles popped off the suture.No further details included.Unsure of actual case type.Unknown if the procedure was completed successfully or if there was any patient harm.No adverse patient consequences were 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.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 via: is it possible to clarify if the procedure was completed successfully? please provide more details.-there were no notes left that there were any issues successfully completing the procedure could you please clarify if there was any patient signs or consequences due to the issue? please provide more information.-no information left for me that there were consequences reported.What is the total number of products involved in this event? i don't know how many needles are involved as they are in a case in a biohazard bag but i'm returning what they provided.Did the event occur during one or multiple patient procedures? to my awareness this applies to one patient.What is the total number of procedures? unknown have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Not specific to this code but other prolene codes if this event occurred in multiple procedures, please provide the following information for each patient event.-i report all events separate as needed.Device return status.Please document the shipment tracking number: i haven't received a return kit yet.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Unknown.It was left for rep by someone from the cv team.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-05099.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV-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 ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17317586
• Report Number: 2210968-2023-05100
• Device Sequence Number: 3996300
• Product Code: GAW
• UDI-Device Identifier: 10705031045774
• UDI-Public: 10705031045774
• Combination Product (Y/N): N
• 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): 07/13/2023

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: M8702
• Device Catalogue Number: M8702
• Device Lot Number: TBBBLB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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