MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 30"(75CM) 6-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP149H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a renal allogeneic transplantation+surgeries: donor kidney removal+surgeries: kidney repair procedure to suture the iliac artery on(b)(6) 2023; and a suture was used.During the procedure, the doctor found that there was no needle at the end of the suture.X-ray confirmed that there were no foreign object left in the patient.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.Additional information was requested, and the following was obtained: - was there any adverse consequence associated with the patient? unknown - was there any additional tissue damage as a result of searching for the needle piece? unknown - what is the surgeon's opinion of consequences to the patient? unknown to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information received: after investigation, the patient was a male of unknown age.On (b)(6) 2023, the patient underwent "main surgery: renal allograft transplantation < right > + donor kidney extraction < left > + renal repair < left >" in hospital.The surgeon used pdp149h for iliac artery sewing (the specific sewing method was unknown) during the surgery.The pull off suture needle occurred during sewing.The doctor immediately look for the needle around the incision, surgical field and operating table.The patient was given intraoperative x-ray examination to assist in finding the needle.After reading the x ray film, it was confirmed that no foreign body was left.The surgeon decided to give up the searching and routinely end the surgery.The needle was not found finally.This event prolonged the surgery time by about half an hour and caused additional radiation damage to the patient due to film screening.The patient recovered well currently and was discharged smoothly.No subsequent adverse events were reported.

• Brand Name: PDS PLUS SUTURE 30"(75CM) 6-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19135176
• Report Number: 2210968-2024-04519
• Device Sequence Number: 17301009
• Product Code: NEW
• UDI-Device Identifier: 10705031047938
• UDI-Public: 10705031047938
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Expiration Date: 06/30/2024
• Device Catalogue Number: PDP149H
• Device Lot Number: SHMDCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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: Male