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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I CERTAIN® 3.4MM(D) DRIVER TIP - SHORT
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BIOMET 3I CERTAIN® 3.4MM(D) DRIVER TIP - SHORT Back to Search Results
Catalog Number IMPDTS
Device Problem Separation Failure (2547)
Patient Problem No Information (3190)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).
 
Event Description
It was reported that the driver (impdts) would not disengage from the implant during surgery.
 
Manufacturer Narrative
One certain® 3.4mm(d) driver tip - short (impdts) was returned for investigation.A visual inspection of the as returned product identified minor signs of use and no apparent malfunction.The returned device was functionally tested with an in-house compatible implant and passed functional testing without any malfunction.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.The alleged device malfunction has been unconfirmed.A root cause cannot be determined.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
CERTAIN® 3.4MM(D) DRIVER TIP - SHORT
Type of Device
DRIVER
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key8178452
MDR Text Key131327165
Report Number0001038806-2018-01034
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIMPDTS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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