MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 96IN 1 S/A XLH LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP881G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
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 a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.
Event or Problem Description
It was reported that a patient underwent an abdominoplasty procedure on (b)(6) 2019 and suture was used.During the procedure, the needle detached from the assembly.The procedure was completed successfully.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Product complaint # : (b)(4).It was received for analysis an empty opened foil, an empty opened folder and needle-suture piece of product code pdp881, lot pbm549.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected and slightly marks were noted on the body needle.The suture was cut appears to be by use of surgical instrument.Due to the condition of the sample the functional test cannot be performed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the sample, it could not be determined what may have caused the reported incident.The reported complaint was observed.

• Brand Name: PDS PLUS VIO 96IN 1 S/A XLH LP
• 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: 9083799
• Report Number: 2210968-2019-87823
• Device Sequence Number: 2622480
• Product Code: NEW
• UDI-Device Identifier: 10705031048676
• UDI-Public: 10705031048676
• 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): 08/23/2019

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: 01/31/2021
• Device Catalogue Number: PDP881G
• Device Lot Number: PBM549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1