MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z341H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device pb6899 batch number, and no non-conformance's 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.The following information was requested, but unavailable: were x-rays or any radiological tests performed? please provide location and size of the needle tip, if retained in the patient.If retained, are any plans in place to remove the needle tip? we do not have additional information.Once we have progress we will notify immediately.
Event or Problem Description
It was reported that a patient underwent a laparoscopic cholecystectomy procedure on (b)(6) 2019 and suture was used.The needle tip broke in the patient at the time of use and it was not found.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 1 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9193205
• Report Number: 2210968-2019-88678
• Device Sequence Number: 2600088
• Product Code: NEW
• UDI-Device Identifier: 10705031060647
• UDI-Public: 10705031060647
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 01/31/2024
• Device Catalogue Number: Z341H
• Device Lot Number: PB6899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1