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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER SCREWDRIVER Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). 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.
 
Event Description
It was reported four screwdrivers have broken springs and can no longer turn a screw when it is engaged in bone. When you turn the proximal knob it just spins. This issue did not affect any surgeries, it was identified while stocking trays. There was no patient involvement.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Functional testing and inspections could not be performed due to the products not being returned and no photographs being provided. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
 
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Brand Name90° CONTRA ANGLE DRIVER
Type of DeviceSCREWDRIVER
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key7639163
MDR Text Key112448721
Report Number0001032347-2018-00405
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
PK142823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
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 Number(01)00841036123130
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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