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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 Problems Failure To Adhere Or Bond (1031); Device Inoperable (1663); Separation Failure (2547)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Patient sex - no information was checked in error as there is no patient involvement.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00881.
 
Event Description
It was reported that while preparing for a product demonstration the sales distributor identified it is almost impossible to load the blades or temporary fixation pins in the driver.If you are able to get a blade/pin loaded in the driver, then you struggle to remove the blade/pin.One of the drivers won¿t turn when blade/pin is loaded.No patient involvement.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.Device history record (dhr) review was unable to be performed as the lot numbers of the devices involved in the event are unknown.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00881-1.
 
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Brand Name
90 DEGREE CONTRA ANGLE SCREWDRIVER
Type of Device
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 Key7113923
MDR Text Key95744134
Report Number0001032347-2017-00880
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK142823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number24-1189
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/15/2017
Initial Date FDA Received12/13/2017
Supplement Dates Manufacturer Received04/10/2018
Supplement Dates FDA Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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