MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 30IN 6-0 D/A BV-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP117H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
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.The following information was requested, but was unavailable: please clarify how the procedure was complete.Please provide lot number.Please provide procedure name and date.Any patient consequences? status of product return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDS+ VIO 30IN 6-0 D/A BV-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10521056
• Report Number: 2210968-2020-06805
• Device Sequence Number: 16978376
• Product Code: NEW
• UDI-Device Identifier: 10705031047877
• UDI-Public: 10705031047877
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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 Model Number: PDP117H
• Device Catalogue Number: PDP117H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1