MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JUGGERKNOT LONG 1 #1 MB; FASTENER, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 04/17/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a hip arthroscopy and labral repair on (b)(6) 2015.During the procedure, the suture anchors pulled out.Additional holes were drilled and two new suture anchors were utilized to complete the procedure.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, number 5 states, "care is to be taken to ensure adequate soft tissue fixation at the time of surgery." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02060 / 02061).

• Brand Name: JUGGERKNOT LONG 1 #1 MB
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4775668
• MDR Text Key: 20810646
• Report Number: 0001825034-2015-02061
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 916030
• Device Lot Number: 668750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention