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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Date 02/24/2015

Event Type  malfunction  

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Measureable dimensions were evaluated and the found component to be within appropriate design specification.

Event Description

It was reported that patient underwent a chondrocyte implant procedure that utilized a soft anchor on (b)(6) 2015.During the procedure, the surgeon noticed the guide sleeve of the soft anchor device was too close to the handle when the sterile pouch of the soft anchor was opened.The surgeon also felt the guide sleeve was loose and opted not to use the soft anchor device.Another soft anchor device was available to complete the procedure without significant delay.

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4621799
• MDR Text Key: 13180190
• Report Number: 0001825034-2015-01082
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/06/2015

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 633590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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