MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8807H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
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: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no patient consequence.What is the total number of products involved in this event?a box of thread: several threads from one box (4-5 threads) had this problem of breaking at the slightest pressure or of the needle becoming loose; the team ended up changing boxes: there were no longer any problems with the threads used in this new box, which had the same reference but a different lot number.How long (in minutes) did the surgery prolong?the operation was extended by only a few minutes, but it is difficult to give a precise estimate.What tissue was being sutured when the event occurred? the right carotid artery.Was additional dissection required in other organs/tissues other than the target tissue?no additional dissection.Was there any change in the patient¿s post operative care due to the prolonged procedure? no change in post-operative care due to prolonged procedure.Events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent a thromboendoarterectomy (tea) of the right carotid artery procedure on (b)(6) 2024 and suture was used.During the procedure, the surgeon wanting to anastomose the carotid artery, used the prolene wire.But on several occasions, the threads broke at the slightest pressure (even minimal) and the needle pulled off.As a result, the staff had to change the box of wires, with the same reference number but unknown lot number.This issue caused a loss of time.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC 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: 18894249
• Report Number: 2210968-2024-02980
• Device Sequence Number: 7738316
• Product Code: GAW
• UDI-Device Identifier: 10705031020719
• UDI-Public: 10705031020719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 8807H
• Device Lot Number: THBJBL
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/18/2024
• 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