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

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  malfunction  

Event Description

According to the survey, 19 users reported a drill break, device pulling out of the bone and/or failing to anchor into bone and pain, discomfort, or abnormal sensation; 20 users reported inability to deploy juggerknot soft anchor into bone using deployment system and, ppe tears/damage (i.E.Glove tear); 15 users reported a reaction, nonunion or delayed union, bending or fracture of the implant, allergic reaction to a foreign body, nerve damage due to surgical trauma,  and, loosening or migration of the implant; 16 users reported bone fracture due to drill; 13 users necrosis of bone or tissue and, intraoperative or postoperative bone fracture and/or postoperative pain; 18 users reported inadequate healing.Survey respondents were given the option to write in additional adverse events encountered that were not listed on the survey.2 out 31 physicians experienced additional adverse events; 1 respondent reported anchor entrapment in soft tissue and another reported "sometimes it pulls out/doesn't hold.".

Manufacturer Narrative

This information is based entirely on a global anonymous survey of 31 physicians.Patient information is limited due to confidentiality concerns.Please note, multiple patients and products with many different serial numbers and lot numbers were referenced within a product family in the survey; therefore, a one-to-one correlation could not be made with unique product serial/lot numbers.The model listed in the report is representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Type of Device: 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: 16585734
• MDR Text Key: 312231992
• Report Number: 3006981798-2023-00010
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K203740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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