MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 0 S/A MO-6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8418H
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
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned.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: were there any patient consequences? none reported.How long was the delay? a few minutes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? none reported.Was there any change in the patient¿s post-operative care due to the prolonged procedure? none reported.Did any needle piece fall into the patient? unknown.If yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? none reported.If not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? do you have any pictures of the device? no.
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on an unknown date and suture was used.During the procedure, the suture, with barely any tension, the suture was falling out of needle, breaking at multiple suture points and at needle base.The suture was passed back and the needle tip was gone.The surgery was prolonged.There were no adverse patient consequences.Additional information was requested.

• Brand Name: PRLNE BLU 30IN 0 S/A MO-6
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19928439
• Report Number: 2210968-2024-08141
• Device Sequence Number: 2725462
• Product Code: GAW
• UDI-Device Identifier: 10705031015357
• UDI-Public: (01)10705031015357(11)221227(17)271130(10)SPBHQM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 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: 8418H
• Device Lot Number: SPBHQM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2022
• 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