MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 patient consequences? no patient consequences.Was the needle piece(s) retrieved during the same procedure? could not be identified on x-ray.What measures were taken to retrieve the broken piece? yes, x-ray.Was there any additional tissue damage as a result of searching for the needle piece? no.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? interoperative x-ray was negative.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2024 and suture was used.During the procedure, it was reported to the sales rep that during a vaginal hysterectomy procedure that the tip of the needle broke off.Tip could not be found during x-ray.Another like device was used to continue with the procedure.There were no adverse consequences reported.No device returning.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 0 S/A CT-2
• 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: 20031320
• Report Number: 2210968-2024-08781
• Device Sequence Number: 6423746
• Product Code: NEW
• UDI-Device Identifier: 10705031060562
• UDI-Public: (01)10705031060562(11)281130(17)231201(10)TPMABB
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• 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): 08/21/2024

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: Z334H
• Device Lot Number: TPMABB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown