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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during a rib fixation case the driver's gears were slipping and the driver would not turn a screw. There was a minimal delay (less than five minutes) and no injury to the patient. Another driver was used to complete the procedure. No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the contra angle screwdriver (part# (b)(4), lot# 763590) showed signs of moderate wear. Functional testing showed that the driver was tough to turn and was frequently sticking during rotation. The driver was disassembled for further inspection and it was found that the internal gears were stripped and metal shavings fell out during disassembly. Device history record (dhr) was reviewed and no discrepancies were found. There are no indications of manufacturing defects. Investigation results concluded that the reported event was due to the gears being stripped, likely resulting from torque in excess of what is required to fixate the screw. 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. In the warnings and precautions section of the instructions for use (ifu) for this product, it states: avoid undue stress or strain when handling or cleaning instruments. The discoloration is most likely due to residual from the cleaning process.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
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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 Key7561355
MDR Text Key109905514
Report Number0001032347-2018-00325
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,health profession
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
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 Number763590
Other Device ID Number(01)00841036123130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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