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	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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.Please clarify a lot number? the following information was requested, but unavailable: could you please clarify the quantity of sutures broken during the procedure on (b)(6) 2020? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted 2210968-2020-09686, 2210968-2020-09687, 2210968-2020-09688, and 2210968-2020-09690.
Event or Problem Description
It was reported that the patient underwent a breast surgery on (b)(6) 2020 and the suture was used.During the surgery, the suture was brittle and broke under minimal tension while suture deeper breast tissue.There were no patient consequences reported.Additional information was requested.

• 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: 10963582
• Report Number: 2210968-2020-09689
• Device Sequence Number: 11815721
• Product Code: NEW
• UDI-Device Identifier: 10705031047952
• UDI-Public: 10705031047952
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: PDP259H
• Device Catalogue Number: PDP259H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1