MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 60IN 0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP990G
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
Product complaint # (b)(4).This medwatch report is in response to receipt of a voluntary medwatch report # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The following additional information was requested but not obtained: event date procedure name.Were the needle pieces removed during same procedure? is the actual device or representative samples available to return for evaluation? if yes, please provide name, mailing address and phone number of the contact person to whom a shipper kit can be mailed out, to aid in return of the product.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 a patient underwent an unknown surgical procedure on an unknown date in (b)(6) 2018 and suture was used.The needle broke during use by surgeon.All pieces of needle retrieved.No adverse patient consequence were reported.

• Brand Name: PDS+ VIO 60IN 0 S/A CTX LP
• 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: 8355710
• Report Number: 2210968-2019-78970
• Device Sequence Number: 2288159
• Product Code: NEW
• UDI-Device Identifier: 10705031048713
• UDI-Public: 10705031048713
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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 Expiration Date: 07/31/2020
• Device Catalogue Number: PDP990G
• Device Lot Number: MJM205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1
• Patient Age: 17 YR