MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP339H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pj5805, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a breast augmentation on (b)(6) 2020 and suture was used.During the procedure, the needle detached from the thread during passage through the tissue.The procedure was successfully completed.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/23/2020.H3 evaluation: one detached needle and a suture inside a labeled winding former were received for analysis.During the visual inspection of sample, the swage and attachment area were not observed as expected; since, the hit of the stake was higher than usual, causing that hit of the stake come across with the solid part of the needle.This condition caused the suture to be separated from the needle resulting in needle pull off.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the suture needle pull off is suggested to be an incorrect swage resulting in a pull-out defect.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-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: 9843200
• Report Number: 2210968-2020-02159
• Device Sequence Number: 19492206
• Product Code: NEW
• UDI-Device Identifier: 10705031048096
• UDI-Public: 10705031048096
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 07/31/2021
• Device Model Number: PDP339H
• Device Catalogue Number: PDP339H
• Device Lot Number: PJ5805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/23/2020
• Patient Sequence Number: 1