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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER

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BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report was submitted to correct the device product code and 510(k) number. The following sections were corrected: device product code: jey corrected to hrs. Pma/510(k) number: k121589 corrected to k142823.
 
Event Description
This follow-up report is being submitted to relay corrected and additional information.
 
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported the surgeon was attempting to seat a screw, as he turned the knob on the driver a "clicking" sound could be heard however it had no torque. It was confirmed the driver was correctly on the head of the screw, however it still did not torque. There was no surgical delay or injury to the patient; the surgeon used the second driver to complete the surgery.
 
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.
 
Manufacturer Narrative
The product identity was confirmed in the evaluation. The device history records were reviewed for the lot and no non-conformances were found. The driver was visually evaluated and it shows signs of normal use. The complaint was confirmed as when the handle (knob) was rotated an inserted blade did not rotate. It was noticed that the head of the driver was a little loose and able to be screwed back into the handle. The loose head would cause the hex not to engage properly. After this, when the knob was rotated an inserted blade would rotate. The driver was then tested with a blade, a screw, and poplar. The blade could be successfully inserted into the driver. The screw was inserted and removed from the poplar with no issues. The complaint is confirmed as upon receipt the driver would not turn a blade. The most likely underlying cause of the complaint was determined to be loosening of the head from the handle.
 
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Brand Name90 DEGREE CONTRA ANGLE SCREWDRIVER
Type of DeviceCONTRA 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 Key6247425
MDR Text Key163874000
Report Number0001032347-2017-00032
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number24-1189
Device Lot Number490190
Other Device ID Number(01)00841036123130(10)490190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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