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

Catalog Number	Z333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
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.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.Lm878 is an invalid lot number.Can you please provide the correct lot number?.
Event or Problem Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2018 and suture was used.During the procedure, the suture broke in the middle of the strand during extracorporal knot tying.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An empty opened foil, a needle/suture piece and a suture piece were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.Marks on body needle that appears to be by the use of a surgical instrument could be observed.The suture pieces were examined and present several damage (dent) along of strands.Also, the ends of the suture pieces present elongation and damaged (cut) that appears to be by the use of a surgical instrument was observed.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Per the open sample condition, the assignable cause of the performance - breakage suture, suggest an improper handling of the sample.

• 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: 7638307
• Report Number: 2210968-2018-73816
• Device Sequence Number: 19369013
• Product Code: NEW
• UDI-Device Identifier: 10705031060548
• UDI-Public: 10705031060548
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 10/31/2022
• Device Catalogue Number: Z333H
• Device Lot Number: LMM878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/31/2018
• Patient Sequence Number: 1