MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 30"(75CM) 5-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP148H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent hypospadias repair on (b)(6) 2019 and suture was used.During the procedure, the suture pulled off the needle.A like device was used to complete surgery.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A detached needle, a needle/suture piece and a labeled winding former with a partially dispensed suture of product were returned for analysis.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected and marks by use of a surgical instrument could be observed, no suture remnant into the hole was noted.During the visual inspection of the needle/suture piece marks by use of a surgical instrument could be observed and the suture end was damaged (flat).The ends of the suture were noted cut and appeared to be by use of a surgical instrument.Per the condition of the sample received, the assignable cause of the suture needle pull off is an improper handling.

• Brand Name: PDS PLUS SUTURE 30"(75CM) 5-0 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: 8741908
• Report Number: 2210968-2019-83406
• Device Sequence Number: 11272717
• Product Code: NEW
• UDI-Device Identifier: 10705031047921
• UDI-Public: 10705031047921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061037
• 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): 06/06/2019

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 Catalogue Number: PDP148H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1