MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC HS FIBER ARTHRO LINK; NONABSORBABLE SURGICAL SUTURE

Model Number	HS216
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "when the reference (b)(4) was checked on receipt, 9 boxes had only one of the two required labels.".
Additional Manufacturer Narrative
No product was returned for evaluation at this time.A review of the device history record was performed and all product met requirements prior to release.The cause for the event was found to be an assembly error and the report has been substantiated.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

• Brand Name: HS FIBER ARTHRO LINK
• Common Device Name: NONABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland
• MDR Report Key: 16742244
• Report Number: 3006981798-2023-00016
• Device Sequence Number: 5377945
• Product Code: GAT
• UDI-Device Identifier: 00812444028645
• UDI-Public: 00812444028645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: HS216
• Device Lot Number: 23012703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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