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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM 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 Date 02/17/2017
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; g5 pma/510(k) number: k121589, corrected to k142823. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00200-2.
 
Event Description
This follow-up report is being submitted to relay corrected and additional information.
 
Manufacturer Narrative
Review of device history records show the lot 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. Report two of two for the same event, reference report 0001032347-2017-00200.
 
Event Description
It was reported the internal gear in two drivers broke during a rib fracture case. A back up driver was used to complete the surgery; there was no delay or injury to the patient.
 
Manufacturer Narrative
Driver lot # 801390 had a very rough rotation when operated indicating excess friction between the meshing gears. The driver head was removed to inspect the gears and there was a large amount of foreign material on the drive shaft gear face that was causing the gears not to mesh correctly. The driver was functionally tested and confirmed to not transmit any torque to the blade. Further inspection revealed the main gear on the drive shaft had sheared the dowel pin that locked it in place and it was able to spin freely on the drive shaft. The most likely cause of this is excessive torque. There are no signs of manufacturing defects. Supplemental report two of two for the same event, reference report 0001032347-2017-00200-1.
 
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Brand NameBIOMET MICROFIXATION FACIAL PLATING SYSTEM
Type of Device90 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 Key6417747
MDR Text Key192230703
Report Number0001032347-2017-00210
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
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2017
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 Number801390
Other Device ID Number(01)00841036123130(10)801390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2017
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 Manufactured04/10/2015
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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