MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 4-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP310H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
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.
Event or Problem Description
It was reported that a patient underwent a total laparoscopic hysterectomy on (b)(6) 2018 and suture was used.During the procedure, the suture was detached from the needle when holding the needle during use under the skin.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/30/2018.Evaluation: a labeled winding former, a detached needle and a 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.The barrel hole no present remnant, but marks on body and edge of needle appear to be by use of the surgical instruments.The end of the suture present marks and a section was noted split due to use.The dhr review could not be conducted, because the batch number of the complaint is unknown.Per the needles condition the assignable cause of the suture needle pull off was an improper handling.

• Brand Name: PDS+ VIO 27IN 4-0 S/A SH-1
• 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: 8019191
• Report Number: 2210968-2018-76830
• Device Sequence Number: 1756248
• Product Code: NEW
• UDI-Device Identifier: 10705031047990
• UDI-Public: 10705031047990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/03/2018

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: PDP310H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/01/2018
• Patient Sequence Number: 1