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	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Summary: sixteen unopened samples of product code pdp259, lot # qhmjrk were received for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the package.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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.What is the specific number of devices (total qty involved) suture broken during this procedure? please confirm the specific number of patient events, per suture product and the quantity of sutures involved.What was used to complete the procedure? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted 2210968-2020-09735, 2210968-2020-09736, 2210968-2020-09737, 2210968-2020-09738, and 2210968-2020-09739.
Event or Problem Description
It was reported that the patient underwent an unknown 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: 10972304
• Report Number: 2210968-2020-09740
• Device Sequence Number: 16761744
• 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 Expiration Date: 06/30/2022
• Device Model Number: PDP259H
• Device Catalogue Number: PDP259H
• Device Lot Number: QHMJRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1