MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JGRKNT 1.0MM MINI 3-0 NDLS; FASTENER, FIXATION

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported patient underwent a ucl procedure on (b)(6) 2013.During the procedure, the plastic sleeves of the juggerknot anchors stuck with the handle.Three of the anchors were pushed through the holes with a point tool while the fourth juggerknot anchor would not engage and the procedure was completed.

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 2 states, "improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure." this report is number 3 of 3 mdrs filed for the same event (reference 1825034-2014-00336 / 00338).

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3573202
• MDR Text Key: 15103515
• Report Number: 0001825034-2014-00338
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 963000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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 Age: 23 YR