MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
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.Did any piece(s) of the needle fall into the patient¿s tissue? if so: was the needle piece(s) retrieved? 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? does a piece of the needle remain in the patient¿s tissue? if yes, what tissue structure is it located? if retained, what is the surgeon's opinion of consequences to the patient? what is the lot number? this medwatch report is in response to receipt of maude event report mw5077531.
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 while suturing inside the vaginal canal, the surgeon encountered something hard (remains unclear whether periosteum or a retractor).The needle broke when it was felt where typically the needle would bend.The surgeon kept the remainder of needle and suture material.There were no patient consequences reported.Additional information has been requested.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-2
• 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: 7780484
• Report Number: 2210968-2018-75139
• Device Sequence Number: 16534342
• Product Code: NEW
• UDI-Device Identifier: 10705031048065
• UDI-Public: 10705031048065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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 Catalogue Number: PDP333H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/14/2018
• Patient Sequence Number: 1