MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; SELF PUNCHING TRIPLE LOADED IMPLANT

Model Number	CM-99145BRN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.There were no nonconformities noted with the lot during production.There were no nonconformities with the raw material used.All finished goods testing requirements were met prior to release.There was no evidence that the device failed to meet specifications and the report could not substantiated.There is a possibility of using the incorrect surgical method for implanting the inserter.Furthermore, if the drill channel is too small or the bone quality is not of acceptable form, this kind of failure is possible.A cause for the event cannot 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 has cause or contributed to the event described in the report.Riverpoint medical 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 fda.
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the inserter of this complaint product couldn't be pulled out after the surgeon inserted the anchor into the patient's burr hole.And the surgeon pulled the inserter to pull it out from the patient's burr hole, then tip of the inserter was fractured and remaining in the patient's burr hole.Fortunately, the fractured piece of inserter could be removed, so there is no remains in the patient's body.".

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Common Device Name: SELF PUNCHING TRIPLE LOADED IMPLANT
• 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: 19303199
• Report Number: 3006981798-2024-00034
• Device Sequence Number: 12445681
• Product Code: MBI
• UDI-Device Identifier: 00810020087215
• UDI-Public: 00810020087215
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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 Model Number: CM-99145BRN
• Device Lot Number: 23061223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown