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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER SCREW DRIVER Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2016
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. (b)(4).
 
Event Description
This follow-up report is being submitted to relay corrected and additional information.
 
Manufacturer Narrative
Review of the device history records show that 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 was reported a contra angle driver that did not function during a procedure. It was reported the driver appeared to be stripped. It was reported the surgeon used the available spare driver. It was reported there was a two minute delay to exchange the drivers.
 
Manufacturer Narrative
The product was returned for evaluation. The product identity was confirmed in the evaluation. The driver was visually evaluated and shows signs of normal use. The driver was tested and found to function as intended with no issues. Therefore, the complaint is unconfirmed. The most-likely cause of the complaint could not be determined as no issue was found. According to the evaluation, there are no indications for manufacturing defects.
 
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Brand Name90 DEGREE CONTRA ANGLE SCREWDRIVER
Type of DeviceSCREW DRIVER
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 Key6138195
MDR Text Key149757411
Report Number0001032347-2016-00726
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 Received12/01/2016
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 Number465660
Other Device ID Number(01)00841036123130(10)465660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
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 Manufactured03/23/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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