MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN USP4-0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z924H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was found that the suture had been detached from the needle.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 01/28/2020.A manufacturing record evaluation was performed for the finished device pe5762 batch number, and no non-conformances were identified.It was received for analysis an empty opened labeled winding former, a detached needle and a suture piece of product code z924h, lot pe5762.Additional h3 device evaluation summary: during the visual inspection of the needle, the swage and attachment area were as expected, and remnant of the suture was noted into the barrel hole and marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.In addition, the ends of the suture were cut appears to be by use of the surgical instrument.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.

• Brand Name: PDSII VIO 27IN USP4-0
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9473586
• Report Number: 2210968-2019-90937
• Device Sequence Number: 2851935
• Product Code: NEW
• UDI-Device Identifier: 10705031114777
• UDI-Public: 10705031114777
• 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): 11/25/2019

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: 04/30/2024
• Device Catalogue Number: Z924H
• Device Lot Number: PE5762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1