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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 Problems Device Inoperable (1663); Separation Failure (2547)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
(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 the sales representative checked the set before delivering to another hospital for a case, and found that the contra angle screwdrivers did not work. One screwdriver was not turning smoothly, it is rough and hard to turn. The other screwdriver is getting harder to turn and after inserting a blade it could not be removed from the screwdriver. No patient involvement.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. The product identities were confirmed. Visual inspection of two 90 degree contra angle screwdrivers (part #24-1189, lot #580850) showed signs of moderate wear. One was sticking minimally and the other was tough to turn. Neither of the screwdrivers would release the blade head from the collet. The internal gears were found to be rusted and stripped. Device history record (dhr) was reviewed and no discrepancies were found. Investigation results concluded that the reported event was due to the blade connection issues that were due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection. 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 Key7378238
MDR Text Key103944339
Report Number0001032347-2018-00151
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,foreig
Type of Report Initial,Followup,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2018
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 Number580850
Other Device ID Number(01)00841036123130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

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