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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP 30MM; DENTAL DRIVER

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BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP 30MM; DENTAL DRIVER Back to Search Results
Catalog Number RASD6
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2024
Event Type  malfunction  
Event Description
Doctor reported that active part of screwing tip fractured when tightening.
 
Manufacturer Narrative
Zimvie complaint number (b)(4).
 
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Brand Name
RIGHT ANGLE SLOTTED DRIVER TIP 30MM
Type of Device
DENTAL DRIVER
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
Manufacturer (Section G)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
carlos gordian-arroyo
4555 riverside drive
palm beach gardens, FL 33410
5619713230
MDR Report Key19114735
MDR Text Key340239938
Report Number0001038806-2024-00748
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/15/2024
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 Catalogue NumberRASD6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Patient EthnicityNon Hispanic
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