MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 2-0 70CM CT1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP259H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Attempts are being 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.What tissue was being approximated or sutured when it broke? what was used to complete the procedure? device return status/follow up? note: event reported via mw# 2210968-2020-09187.
Event or Problem Description
It was reported that the patient underwent breast surgery on an unknown date and suture was used.During the procedure, the suture broke mid strand during procedure.The physician reported she was not applying significant force to suture at the time of breakage.The case was completed with no patient consequences.

• Brand Name: PDS PLUS CLR 2-0 70CM CT1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10879876
• Report Number: 2210968-2020-09188
• Device Sequence Number: 3766482
• Product Code: NEW
• UDI-Device Identifier: 10705031047952
• UDI-Public: 10705031047952
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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 Expiration Date: 06/30/2022
• Device Model Number: PDP259H
• Device Catalogue Number: PDP259H
• Device Lot Number: QHMJRK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/12/2020
• Patient Sequence Number: 1