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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
(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 two (2) contra angle drivers do not turn properly. This was identified by the sales distributor upon receipt of the drivers. There was no patient involvement.
 
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 contra angle screwdrivers (part# 24-1189, lot# 421480) showed signs of moderate wear, with minor scratching and discoloration on the bodies of the screwdrivers. Functional testing showed one screwdriver was sticking during rotation and the other would not rotate a blade. The driver s were disassembled for further inspection and it was found that the internal gears were rusty and some metal shavings fell out during disassembly. Device history record (dhr) was reviewed and no discrepancies were found. Investigation results concluded that the reported event was due to the gears being stripped, likely resulting from excessive force by over torqueing. In the warnings and precautions section of the instructions for use (ifu) for this product it is stated ¿avoid undue stress or strain when handling or cleaning instruments. ¿ the discoloration is most likely due to residual from the cleaning process. 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 Key7558470
MDR Text Key109759503
Report Number0001032347-2018-00324
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 10/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
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 Number421480
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?
Event Location No Information
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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