MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; FIXATION DEVICE

Model Number	CM-99529B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the anchor was pulled out from the patient's burr hole.Therefore, the surgeon made another burr hole and implanted a back up of the same product's anchor into it.".
Additional Manufacturer Narrative
The device was returned for evaluation.No nonconformities were noted on the product.The anchor length and width met requirements.A review of the device history record was performed and all product met requirements prior to release.The report could not be substantiated and a cause for the event could not be established.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: JUGGERKNOT SOFT ANCHOR
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 17502624
• Report Number: 3006981798-2023-00043
• Device Sequence Number: 6796570
• Product Code: MBI
• UDI-Device Identifier: 00810020087338
• UDI-Public: 00810020087338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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: CM-99529B
• Device Lot Number: 22081621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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