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

Model Number	CM-99114BN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the tip of inserter was fractured while the surgeon tried to implant an anchor into the patient's burr hole.This incident occurred on the 3 products, and 1 of 3 products was discarded in the hospital.And the fractured piece of inserter of the 1 of 3 complaint products is "remaining" in the patient's body.And it was reported as well that the surgeon didn't "use" a guide when he tried to implant an anchor.".
Additional Manufacturer Narrative
Product was not returned for evaluation.A review of the device history record was performed and all product met requirements prior to release.There was no evidence that the device failed to meet specifications, and the report could not be substantiated.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 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: 17674603
• Report Number: 3006981798-2023-00052
• Device Sequence Number: 20341638
• 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): 09/01/2023

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-99114BN
• Device Lot Number: 22021521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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