MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z452H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pmu402, and no non-conformance's 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.Additional information was requested and the following was obtained: were x-rays taken to locate the needle?the needle was not lost in the dog's body, it was detached from the thread during use, and it was removed during the procedure.No other information.Was the needle piece removed from the patient during the same procedure? yes.Was there any patient consequence or injury? no patient consequence.What is the condition of the patient? no damage of the patient's health.
Event or Problem Description
It was reported that a dog underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, when the veterinarian was pricking with the needle, the needle detached from the thread and without exerting excessive tension to the thread.No consequences to the dog.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: it was reported pull off - suture needle.Three unopened samples of product code z452, lot pmu402 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of the unopened samples, no defects were observed on the packets.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damaged were noted.Functional test was performed on the samples and the pull force did not meet the minimum ltl.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, the assignable cause of performance - pull off suture needle is a pull-out due to light swage was found.Additional investigation summary: thirty unopened samples of product code z452, lot pmu402 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of the samples, no defects were found on the packages.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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-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: 9903094
• Report Number: 2210968-2020-02476
• Device Sequence Number: 11387007
• Product Code: NEW
• UDI-Device Identifier: 10705031061026
• UDI-Public: 10705031061026
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 10/31/2024
• Device Model Number: Z452H
• Device Catalogue Number: Z452H
• Device Lot Number: PMU402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/16/2020
• Patient Sequence Number: 1