MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z423H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Procedure name? when was it noticed sutures broke? pre-op/before use on patient (while in package?, during dispensing?, during prep at or table?, other? ) or intra-op/during use on patient while suturing? while tying knots? please can you confirm the total qty of sutures involved that presented breakage issue during the single procedure/single patient event ? it is stated qty involved= 6, is this correct? did all 6 sutures break during same procedure from the same batch/lot? if not, can you provide the total number of procedures/patient events where suture breakage issue noticed? have any of these events been previously reported to ethicon? if yes, please provide complaint file reference number for each patient event please provide: event date, product code and lot number involved, procedure, event description, was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed?.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and suture was used.The sutures kept breaking during use.The procedure was completed with an alternate like device with no patient consequences reported.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda:(b)(4) 2018.Six unopened samples of product code (b)(4), lot ma6843 were received for analysis.The issued sample was not received for evaluation.During the visual inspection of the samples, no defects were found on the package, the samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or breakage suture were observed.A functional test was performed and the tensile force were above the minimum requirements.Per the condition of the representative samples, no performance - breakage suture was found on the sutures and the tested sample met the finished goods requirements,.

• Brand Name: PDS II POLYDIOXANONE SUTURE
• 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: 7693933
• Report Number: 2210968-2018-74424
• Device Sequence Number: 16496236
• Product Code: NEW
• UDI-Device Identifier: 10705031060913
• UDI-Public: 10705031060913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 12/31/2022
• Device Catalogue Number: Z423H
• Device Lot Number: MA6843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 1