MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 5-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP303H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mg6475 number, 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 the patient underwent rhinoplasty on (b)(6) 2019 and suture was used.During the procedure, the suture uncoupled from the needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 4/7/2020.H3 evaluation: one empty opened foil, a detached needle and dispensed suture of product code pdp303, lot mg6475 were returned for analysis.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected.The suture was examined and the end is severely cut resulting in a clip off defect.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 performance ¿ needle pull off, is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: PDS+ VIO 27IN 5-0 S/A RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8896324
• Report Number: 2210968-2019-85602
• Device Sequence Number: 13532576
• Product Code: NEW
• UDI-Device Identifier: 10705031047969
• UDI-Public: 10705031047969
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/19/2019

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: 05/31/2020
• Device Model Number: PDP303H
• Device Catalogue Number: PDP303H
• Device Lot Number: MG6475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1