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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
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.A manufacturing record evaluation was performed for the finished device lot number: qhmjrk / pdp259h, and no non-conformances related to the reported complaint condition were identified.Note: events reported via mw # 2210968-2020-09717, 2210968-2020-09718, 2210968-2020-09719, 2210968-2020-09720.
Event or Problem Description
It was reported that the patient underwent a breast procedure on an unknown date and suture was used.During the procedure, the suture was found to be brittle and broke mid-strand under minimal tension while suturing deeper breast tissue.It was reported that significant force was not applied at the time of suture breakage.There were no adverse patient consequences reported.

• 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: 10971357
• Report Number: 2210968-2020-09716
• Device Sequence Number: 16676168
• Product Code: NEW
• UDI-Device Identifier: 10705031047952
• UDI-Public: 10705031047952
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 11/23/2020

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): Initial
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1