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

Model Number	CM-99114BN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and there were no issues noted during production.All finished goods testing requirements were met prior to release.The inserter raw material specifications were reviewed and all requirements were met prior to release.No inserters were available from the lot used in this device.A cause for the event has not been established and the report cannot be substantiated.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.
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the anchor of this complaint product pulled out unintended although the surgeon implanted it following normal usage, and it was confirmed that the tip of inserter was fractured.There is the possibility that the fractured piece of inserter has be remained in the patient's body.".
Additional Manufacturer Narrative
Product was returned and was sent to the supplier for further analysis.The supplier evaluation indicated no manufacturing defects on the sample.A review of the device history record was performed and all product met requirements prior to release.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: 16857520
• Report Number: 3006981798-2023-00023
• Device Sequence Number: 20989259
• 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,Followup
• Report Date (Section B): 11/20/2023

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?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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