MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 2-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z466H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 an animal underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture snapped partway down the length during normal use.There were no adverse consequences.No additional information was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/1/2019.Evaluation: an opened box with thirty-one unopened samples were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of thirteen unopened samples, no defects were observed on the packets.The samples were opened and the swage and attachment area were noted to be as expected.The sutures were examined along strand and no defects or damages were noted.A functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no suture breakage was observed and the tested sample met the finished goods requirements.

• Brand Name: PDS II SUTURE 27"(70CM) 2-0 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: 8125600
• Report Number: 2210968-2018-77454
• Device Sequence Number: 16709621
• Product Code: NEW
• UDI-Device Identifier: 10705031061057
• UDI-Public: 10705031061057
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 11/30/2022
• Device Catalogue Number: Z466H
• Device Lot Number: LPZ834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/02/2019
• Patient Sequence Number: 1