MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC PDM; SUTURE

Model Number	D497
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr for the device was performed and there were no issues noted for needle attachment during manufacturing.The device passed all finished goods testing requirements, including needle attachment testing.Additional testing from manufacturing retains of this lot confirmed intermittent inadequate needle attachment strength per usp requirements.A summary of the testing is provided in the attachment to this report.A review of complaint trending for the product did not reveal any prior needle detachment events for this product.A cause of the event has not been established and there are no defective products in the field.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "we have been having a problem with the 3-0 pdm suture on ps-2 needle.We have one box with 2 left, and a full unopened box.Of the 8 we've used dr." "and i can think of 4 of the needles falling off, two of which were today during surgery.".

• Brand Name: PDM
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 12488237
• Report Number: 3006981798-2021-00023
• Device Sequence Number: 19859286
• Product Code: NEW
• UDI-Device Identifier: 00812444029291
• UDI-Public: 00812444029291
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K100461
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: 04/30/2024
• Device Model Number: D497
• Device Lot Number: 19050616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1