MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; SINGLE LOADED IMPLANT WITH NEEDLES

Model Number	CM-99114BN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the inserter couldn't be pulled out easily from the patient's burrhole after the surgeon inserted the anchor.Finally, he could pull out the inserter from the patient's burr hole, but it was found that the tip of inserter was fractured.He pulled out the anchor from the patient's burr hole to try to remove the fractured piece of inserter, but it couldn't be done.So, he decided to finish the surgery without removing the fractured piece of inserter from the patient's body.".
Additional Manufacturer Narrative
The device was returned for evaluation.The evaluation of the device is still ongoing.A review of the device history record was performed and all product met requirements prior to release.The report has not been substantiated and a cause for the event has not been established.The investigation is ongoing.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: SINGLE LOADED IMPLANT WITH NEEDLES
• 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: 15954786
• Report Number: 3006981798-2022-00047
• Device Sequence Number: 17998765
• Product Code: MBI
• UDI-Device Identifier: 00810020087116
• UDI-Public: 00810020087116
• 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): 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: CM-99114BN
• Device Lot Number: 21030829
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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