MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z310H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Photo analysis: during the visual analysis, the following was observed: the photo shows two open and empty boxes, each one identified with its specifications according to batch: qgmjmu pdsii vio 27inc usp4-0 and batch: lbz234 pdsii vl 27.Based on the set of photos review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance." 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 there any adverse consequence associated with the patient? there were no adverse consequences to the patient.The surgeon was passed the suture and when she pulled it out she noted the needle was not tapered.She refused to use it since she needed a taper needle to not damage the delicate tissues she was working on.What is the lot number? i have found three affected lots, qgmjmu, qbmjcj, and rjmhld.Device return status: we have not yet initiated a return with the vendor we purchased them from (pharmsource wholesale).What is the delivery / order number? the last delivery/order i can find a record of was from pharmsource wholesale.That order was placed on june 9th 2021.Their order number was 2100015511.Can you please provide the invoice? unfortunately we cannot.Our pricing with vendors is confidential.Are there any pictures available? yes, please see the attachment.It will show the package on the left with the spatula needle instead of the usual taper needle which is shown on the right.What is the carrier associated with the delivery? they were delivered by ups air.If available, what is the container lp number (lp: license plate associated with the shipment)? i do not have this information.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 procedure on an unknown date and suture was used.During the procedure, the surgeon noticed that the needle was a spatula needle.For years this product came with a taper needle, but the product was recently changed to have a spatula needle instead.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13896293
• Report Number: 2210968-2022-02166
• Device Sequence Number: 14423776
• Product Code: NEW
• UDI-Device Identifier: 10705031060418
• UDI-Public: 10705031060418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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 Model Number: Z310H
• Device Catalogue Number: Z310H
• Device Lot Number: QGMJMU QBMJCJ RJMHLD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown