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

Model Number	CM-99115B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the tip of the complaint product's inserter was fractured while the surgeon tried to insert the anchor into the patient' burr hole, and the fractured piece of inserter has been remained in the patient's body.And the anchor couldn't be implanted.The above same incident occurred on the 2 same products.Therefore, the surgeon used a back up another product for the surgery.".
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 tip of the complaint product's inserter was fractured while the surgeon tried to insert the anchor into the patient' burr hole, and the fractured piece of inserter has been remained in the patient's body.And the anchor couldn't be implanted.The above same incident occurred on the 2 same products.Therefore, the surgeon used a back up another product for the surgery.".
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.Correction: removed "congenital anomaly/birth defect" from outcomes attributed to adverse event given that no adverse event was reported.

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Common Device Name: SINGLE 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: 20847459
• Report Number: 3006981798-2024-00050
• Device Sequence Number: 7942418
• Product Code: MBI
• UDI-Device Identifier: 00810020087154
• UDI-Public: 00810020087154
• 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,Followup
• Report Date (Section B): 01/14/2025

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-99115B
• Device Lot Number: 23052603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2023
• 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: Congenital Anomaly
• Patient Sex: Unknown