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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 Date 06/08/2018
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 a 90 degree screw driver came loose in a rib case. The screwdriver was being used to drive screws and the head seemed to come loose and start to turn and make it very difficult to use. Backup 90 degree screwdrivers were used to complete the surgery. There was no harm in the case and no delay. The case went well. 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. 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: 0001032347-2018-00542.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. The 90 degree contra angle screwdriver, part# 24-1189, lot# 008100 and lot# 191750, were visually evaluated. Both drivers showed signs of use with some minor discoloration. The drivers were functionally tested by driving a locking screw into a block of white oak wood, using a contra angle traumaone cross-drive blade. Both drivers were able to insert the screw into the block of white oak as intended, with minimal sticking during rotation of the knob. Device history records were reviewed and no discrepancies were found. There are no indications of manufacturing defects. The complaint was not confirmed. 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. The following sections were updated: a5 ethnicity b4 date of this report g4 date received by manufacturer g7 type of report and follow-up number h2 follow-up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00542-1.
 
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 Key7659095
MDR Text Key113272067
Report Number0001032347-2018-00430
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,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
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 Number008100
Other Device ID Number(01)00841036123130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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