MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 60IN 0 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP991G
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
(b)(4).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.What was being done when the suture broke (removal from package / during passage through tissue / during tying / post-op)? were there any adverse patient consequences? was there any medical or surgical intervention to treat the patient consequence? is the lot number of the suture known?.
Event or Problem Description
It was reported that a patient underwent a hernia procedure on unknown date and suture was used.During the procedure, the suture broke.A different device was used to complete the procedure with no adverse patient consequences.Additional information was requested.

• Brand Name: PDS+ VIO 60IN 0 S/A TP-1 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: 7422928
• Report Number: 2210968-2018-72090
• Device Sequence Number: 69746
• Product Code: NEW
• UDI-Device Identifier: 10705031048720
• UDI-Public: 10705031048720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/20/2018

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: PDP991G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1