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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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00105.
 
Event Description
It was reported the drivers are "catching".The issue was discovered prior to use in a procedure.Additional drivers were used to complete the procedure successfully.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.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the two (2) returned contra angle drivers was performed.For the driver with s/n 893200, it appears to be in good overall condition as well; there is some discoloration and brown residue noted at the driver collet.There is also some resistance when making one full rotation.The product was functionally tested using a contra angle traumone blade, cross-drive (part #sp-2379) to drive a 2.4 x 20 mm screw (part #73-2416) into a block of poplar wood.The product was able to drive the screw and functioned as intended, but there was significant sticking noted.Therefore, the complaint that the driver is "catching" is confirmed.The screwdriver was disassembled for further investigation and inspection; it was noted that there was more brown residue at the working end of the driver, though the origin cannot be determined.The driver could not be fully disassembled.The most likely underlying cause of the complaint is the gears being stripped, likely a result of excessive force from over torqueing by the surgeon.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.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: 0001032347-2018-00105-1.
 
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Brand Name
90° CONTRA ANGLE DRIVER
Type of Device
SCREWDRIVER
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key7303454
MDR Text Key101378661
Report Number0001032347-2018-00106
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 company representative
Type of Report Initial,Followup
Report Date 08/06/2018
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 Health Professional
Device Model NumberN/A
Device Catalogue Number24-1189
Device Lot Number893200
Other Device ID Number(01)00841036123130(10)893200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Initial Date Manufacturer Received 02/01/2018
Initial Date FDA Received02/28/2018
Supplement Dates Manufacturer Received06/19/2018
Supplement Dates FDA Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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