MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A C-1 VB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8307H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.(b)(4).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.Additional information was requested, and the following was obtained: what was being done when the needle pulled-off (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)?by pass.Were x-rays taken to locate the needle? yes.Was the needle piece removed from the patient during the same procedure? yes.Does the needle remain in the patient¿s tissue?no."what tissue structure is it located? size of the needle retained vein are any plans in place to remove the needle piece in future?" doesn¿t applay.If retained, what is the surgeon's opinion of consequences to the patient? doesn¿t applay.Was there any patient consequence or injury? what medical/surgical intervention was provided? increased time of opperative.What is the condition of the patient? ok.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.Was additional dissection required in other tissues other than the target tissue? if yes, please describe.Was the post-operative care altered in anyway due to the prolonged surgery time of 1 hour? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? lot number? device return status?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the thread was separated from the needle, which resulted in the extension and search for the needle up to 1 hour.The needle was removed during the procedure.There were no adverse patient consequences reported.The current condition of the patient was reported as ok.Additional information was requested.

• Brand Name: PRLNE BLU 30IN 6-0 D/A C-1 VB
• 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: 16300010
• Report Number: 2210968-2023-00817
• Device Sequence Number: 15145479
• Product Code: GAW
• UDI-Device Identifier: 10705031014183
• UDI-Public: 10705031014183
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 02/03/2023

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: 8307H
• Device Catalogue Number: 8307H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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