MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: peter r.G.Brink., et al 2015, ¿distal oblique bundle reinforcement for treatment of druj instability¿, journal of wrist surgery, vol.4, pages 221-228 (netherlands).This article emphasizes on the procedure for a new technique using a tendon graft to reinforce the distal edge of the interosseous membrane.Between january 1, 2011, and october 31, 2013, all patients complaining of bidirectional druj instability (a combination of palmar subluxation in supination and dorsal subluxation in pronation) referred to the department of traumatology of the (b)(6) medical center were prospectively included in this observational study and treated using the dob reinforcement technique described in subsequent paragraphs.In case of a simultaneous malunion of the radius (both dorsal tilt and radial shift), only patients with persistent instability after correction of the malunion were included.Functional outcomes were determined using the disabilities of the arm, shoulder, and hand (quickdash) score and the patient-rated wrist/hand evaluation (prwhe) prior to treatment and at follow-up.The article describes the following technique: a percutaneous technique is used to harvest the palmaris longus tendon and to create a tunnel, just proximal to the sigmoid notch, through the ulna and radius in an oblique direction.By overdrilling the radial cortex, the knotted tendon can be pulled through the radius and ulna and the knot blocked at the second radial cortex, creating a strong connection between the radius and ulna at the site of the distal oblique bundle (dob).The tendon is fixed in the ulna with a small interference screw in full supination, preventing subluxation of the ulna out of the sigmoid notch during rotation.The device involved: g2 mitek anchor (depuy synthes, inc., (b)(4), usa).Fourteen patients were treated with this novel technique between 2011 and october 2013.The quickdash score at 25 months postoperatively (range 16-38 months) showed an improvement of 32 points.Similarly, an improvement of 33 points (67-34 months) was found on the prwhe.Only one recurrence of chronic, dynamic bidirectional instability in the druj was observed.Postoperatively, 13 out of 14 patients were no longer experiencing the acute, sharp pain of subluxation.In one patient with ongoing osteoarthritis of the druj, the dob reinforcement was eventually replaced by a constrained distal ulna prosthesis.During placement of the prosthesis, the tendon was found to be still intact and firmly fixed to the bone.One patient sustained a fracture of the ulna shaft after several attempts to fix the ulna to the radius in neutral position.The fracture healed after 4 weeks of cast immobilization.One patient had some persistent numbness in the area of the dorsal branch of the radial nerve.Finally, in only one patient did the reconstruction fail outright.As an adams/berger procedure was also unsuccessful, placement of a distal prosthesis was indicated.This simple percutaneous tenodesis technique between radius and ulna at the position of the distal edge of the interosseous membrane shows promise in terms of both restoring stability and relieving complaints related to chronic subluxation in the druj.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9134614
• MDR Text Key: 166426896
• Report Number: 1221934-2019-58670
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention