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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 was reported the 90 degree contra angle driver broke.The distributor advised he is unaware of any patient injury or delay in procedure.More information was requested but has not been received at this time.

Manufacturer Narrative

One 90 degree contra angle screwdriver was returned without packaging.The contra angle screwdriver was visually evaluated and found to be in overall good condition.When turning the knob, some friction was felt during parts of the turn.The driver was able to retain a blade, and was functionally tested by inserting a screw into a pre-drilled hole in a white oak block.While inserting/removing the screw, some friction was felt occasionally.The driver was disassembled for further inspection.The internal gearing components were found to have substantial discoloration, including in the head gear/bearing assembly, which prevented smooth rotation.There were scratches indicating normal use of the instrument.The complaint was confirmed as the contra angle screwdriver would not always rotate smoothly.For the contra angle screwdriver, substantial discoloration was found on the internal components, therefore, the most likely cause was determined to be improper cleaning/rinsing of the instrument.The instructions for use for this instrument states in the "sterility" section that, ¿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.¿ the non-conformance database was reviewed and there was a non-conformance found regarding the difficulty rotating 90 degree contra angle screwdriver.There are no indications of manufacturing defects.

• 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: 6594236
• MDR Text Key: 76073737
• Report Number: 0001032347-2017-00409
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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: 562908
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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