MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; BONE SCREW

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It is reported during neuro surgery five of the 5mm screws broke and the tips were retained in the patient's bone.The surgery was completed using 4mm screws.

Manufacturer Narrative

The part and lot identity was reported by the customer, however this could not be confirmed due to the fact that the tips of the screws were not returned.The five screws were visually evaluated using a digital microscope.They were found to be fractured at the first minor diameter from the head and perpendicular to the length of the screw.The fracture is typical of an over torqued screw.Some of the fragmented tips remain in the patient.There is no sign of discoloration.The slots in the head show signs of use but no significant damage, indicating the screws retained the blade allowing a high torque on the screws to be achieved.The thread dimensions could not be measured due to the location of the fracture.The damage to the screws happened after the manufacture of the screw as the green anodized layer has been worn off in the areas of damage.There are no indications of manufacturing defects.The most likely cause of the complaint issue is excessive torque applied during insertion of the screws.

• Brand Name: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5034814
• MDR Text Key: 24250637
• Report Number: 0001032347-2015-00363
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/28/2015

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6105
• Device Lot Number: 296820
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other