MAUDE Adverse Event Report: ETHICON INC. PDSII SUTURE 96IN (224CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z880G
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).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and is not available: what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? were x-rays taken to locate the needle piece(s)? at what location was the needle found? was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? 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 procedure on an unknown date and suture was used.Suture needle broke off inside patient.Piece retrieved.There was no patient consequence reported.

• Brand Name: PDSII SUTURE 96IN (224CM) 1 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: 8196330
• Report Number: 2210968-2018-78024
• Device Sequence Number: 2165390
• Product Code: NEW
• UDI-Device Identifier: 10705031061903
• UDI-Public: 10705031061903
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2018

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: 05/31/2023
• Device Catalogue Number: Z880G
• Device Lot Number: MG5319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1