MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records shows the lot was released with no recorded anomaly or deviation.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 a 90 degree angle driver is not turning right.It is suspected a gear may be broken.More information was requested but has not yet been received.

Manufacturer Narrative

The screwdriver was returned without packaging.The product was visually evaluated and it was found to be good overall condition.There were scratches and normal signs of wear on the instrument; no significant discoloration was observed.There is some friction when rotating the knob.The complaint was confirmed as there is friction while rotating the knob on the driver.The driver was disassembled for closer inspection.There was some discoloration found in the gearing of the device.The most likely cause of the complaint is determined to be due to chemical residual and discoloration from improper cleaning technique.In the sterility section of the instructions for use it is stated, ¿staining and spotting may result on instruments that are steam sterilized if the instruments are not completely rinsed and free from residual chemicals.It is vital that proper drying cycles and the equipment manufacturer¿s recommendations are followed to prevent the formation of excess moisture and resultant water spotting.¿ there are no indications of manufacturing defects and no updates to the risk assessments needed.

• Brand Name: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• 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: 6639800
• MDR Text Key: 77558140
• Report Number: 0001032347-2017-00499
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 172350
• Other Device ID Number: (01)00841036123130(10)172350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1