MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JGRKNT 1.0MM MINI 2-0 NDLS; FASTENER, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem Osteolysis (2377)

Event Date 03/28/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a scapho-lunate repair procedure on (b)(6) 2014.During the procedure, the anchors pulled out after insertion due to poor bone quality.The procedure was completed by drilling additional holes and using different juggerknots.There was no delay in the procedure greater than 30 minutes.

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 9 states, "inadequate fixation at the time of surgery can increase the risk of loosening and migration of the device or tissue supported by the device.Sufficient bone quantity and quality are important to adequate fixation and success of the procedure.Bone quality must be assessed at the time of surgery.Adequate fixation in diseased bone may be more difficult.Patients with poor quality bone, such as osteoporotic bone, are at greater risk of device loosening and procedure failure." examination of returned device found no evidence of product non-conformances.The surgeon tried to use 3 devices but the bone quality prevented successful implantation.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-03430 & 03431).

• Brand Name: JGRKNT 1.0MM MINI 2-0 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: 3781102
• MDR Text Key: 4435790
• Report Number: 0001825034-2014-03430
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2014

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: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 709200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention