MAUDE Adverse Event Report: ETHICON INC. PDSII MONO VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D10057
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The suture was detached easily from the suture during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional: a dispensed suture and a detached needle of product code d10057 were returned for analysis.During the visual inspection of detached needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The device history review could not be conducted, because the batch number of the complaint is unknown.Per the sample condition, the assignable cause of the pull off suture needle was a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• Brand Name: PDSII MONO VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8386925
• Report Number: 2210968-2019-79230
• Device Sequence Number: 11323290
• Product Code: NEW
• UDI-Device Identifier: 10705031134324
• UDI-Public: 10705031134324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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 Catalogue Number: D10057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/21/2019
• Patient Sequence Number: 1