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

Catalog Number UNK GII ANCHOR

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Tissue Damage (2104); Injury (2348); Not Applicable (3189)

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.Concomitant medical products: unknown.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: silver, m.D.Et al (2000), "symptomatic interarticular migration of glenoid suture anchors" arthroscopy: the journal of arthroscopic & related surgery, vol.16 (1), pages 102-105 (usa).This study emphasizes on: a case report of a (b)(6) male patient who had a bankart lesion.Surgery was performed by placing 3 mitek gii sutures anchors to secure the capsular repair (mitek, westwood, ma).After several weeks of rehabilitation, he began noticing increasing pain and crepitus.The symptoms were most notable with abduction internal rotation of the arm.Complications mentioned in the article were: mild decrease in the range of motion with normal muscle strength upon physical examination.Crepitus was noted with abduction and rotation.Pain upon anterior apprehension testing.Radiograph showing prominent interarticular suture anchor (fig 1).Computed tomography scan of left shoulder confirming interarticular position of the head of the suture anchor (fig.2) arthroscopic view of the left shoulder showing the prominent suture anchor in the anterior inferior quadrant of the glenoid (fig.3).Arthroscopic view of the left shoulder shows relationship of the prominent suture anchor to the humeral head and the subsequent articular cartilage defect created (fig 4).Arthroscopic view of the left shoulder after removal of the suture anchor showing remaining articular defect on the humeral head caused by the prominent suture anchor (fig.5) at 6-month follow up, although his pain had diminished and his shoulder was stable, he was still bothered by crepitus and catching with the arm in abduction and internal rotation.

• 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: 9267269
• MDR Text Key: 185002595
• Report Number: 1221934-2019-59380
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/29/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR