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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 Date 02/06/2017
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. 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
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.
 
Event Description
It is reported the internal mechanism of the contra angle driver broke and the wheel no longer rotated the blade. The additional contra angle driver in the set was used to complete the surgery. There was a twenty minute delay. The distributor associate stated the resident who was using the driver was not turning the wheel over extensively.
 
Manufacturer Narrative
The product was returned in a biohazard bag and therefore could not be functionally tested. The product handle was turned through the bag and no resistance was felt. The most likely cause of the of the complaint could not be determined.
 
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Brand Name90 DEGREE CONTRA ANGLE SCREWDRIVER
Type of DeviceSCREWDRIVER
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 Key6381101
MDR Text Key191620476
Report Number0001032347-2017-00169
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2017
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 Number056380
Other Device ID Number(01)00841036123130(10)056380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2016
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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