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

Model Number	Z333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: could you please explain what do you refer by "adverse event serious injury was reported".What is the current condition of the patient? the patient had to have a slight increase in incision and xray to find the tip and retrieve it.Patient has been released without complication.A manufacturing record evaluation was performed for the finished device lot pm6904, 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.This medwatch report is in response to receipt of maude event report mw#5093553.
Event or Problem Description
It was reported that a patient underwent a laparoscopic procedure on (b)(6) 2020; and a suture was used.During the procedure, the taper needle tip broke off while closing abdominal fascia.The patient had to have a slight increase in incision and an x-ray to find the tip and retrieve it.Patient has been released without complication.No additional information could be provided.

• Brand Name: PDSII VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9959692
• Report Number: 2210968-2020-03021
• Device Sequence Number: 2764638
• Product Code: NEW
• UDI-Device Identifier: 10705031060548
• UDI-Public: 10705031060548
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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: 10/31/2024
• Device Model Number: Z333H
• Device Catalogue Number: Z333H
• Device Lot Number: PM6904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1