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

Model Number	PDP340H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: what was used to complete the procedure? no further information is available.Was the surgery completed successfully? no further information is available.Was the needle piece removed from the patient during the same procedure? no further information is available.Were x-rays taken to locate the needle? no further information is available.A manufacturing record evaluation was performed for the finished device lot pbk490, and no non-conformances were identified.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 laparoscopic ob-gyn procedure on an unknown date; and a suture was used.During the procedure, the suture pulled off from the needle while passing through the tissue.It was not a control release needle.There were no adverse consequences to the patient reported.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/29/2020.Corrected information: d3,g1,g2.Additional information: d10.H3 evaluation: one detached needle of product was received for analysis.During visual inspection of the needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted, and marks were observed on the body needle that appear to be by the use of a surgical instrument.In addition, the suture was not received for evaluation to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the reported issue could not be determined.

• Brand Name: PDS+ VIO 27IN 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: 9947911
• Report Number: 2210968-2020-02839
• Device Sequence Number: 3355049
• Product Code: NEW
• UDI-Device Identifier: 10705031048102
• UDI-Public: 10705031048102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/19/2020

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: 05/31/2021
• Device Model Number: PDP340H
• Device Catalogue Number: PDP340H
• Device Lot Number: PGZ897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1