MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER

Model Number CM-99215

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.A review of the dhr for the lot was performed and no issues were noted during manufacturing and all finished goods testing requirements were met prior to lot release.Investigations performed did not reveal any issue with the product and the report could not be substantiated.This report and use of categorical definitions required by fda 3500a does not constitute an admission by 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 medical device reporting regulation 21 cfr part 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 Description

According to the reporter, "it was reported that during surgery, the suture of this complaint product became able to slide when the surgeon applied tension to the suture.".

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Type of Device: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER
• 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 ; 5035178001
• MDR Report Key: 14779856
• MDR Text Key: 302940995
• Report Number: 3006891798-2022-00019
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00810020087246
• UDI-Public: 00810020087246
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CM-99215
• Device Lot Number: 21021831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1