MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 5-0 S/A P-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z503G
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
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Additional information was requested and the following was obtained: clarify how many sutures broke? 4 sutures broke.How many sutures separated from the needle when removing from the package? 2 broke from swage.Confirm that all sutures reported were from lot lc8048? all were from the same lot and box.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.Please provide further clarification: were there a total of 4 sutures that had issues, where 2 of the 4 sutures broke during the procedure and 2 of the 4 sutures broke from the swage when removing from the package? or were there a total of 6 sutures that had issues, where 4 of the 6 sutures broke during the procedure and 2 of the 6 sutures broke from the swage when removing from the package?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture kept breaking while stitching.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/09/2019.Additional information was requested and the following was obtained: a total of 4 sutures had issues, where 2 of the 4 sutures broke during the procedure and 2 of the 4 sutures broke from the swage when removing from the package.

• Brand Name: PDSII CLR 18IN 5-0 S/A P-2 PRM
• 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: 8107836
• Report Number: 2210968-2018-77355
• Device Sequence Number: 14019894
• Product Code: NEW
• UDI-Device Identifier: 10705031061262
• UDI-Public: 10705031061262
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/30/2018

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: 02/28/2022
• Device Catalogue Number: Z503G
• Device Lot Number: LC8048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1