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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL DRIVER

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BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG; DENTAL DRIVER Back to Search Results
Catalog Number IIPDTUL
Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)
Patient Problem Insufficient Information (4580)
Event Date 11/02/2021
Event Type  Injury  
Event Description
It was reported that after the doctor completed the osteotomy, the implant was unable to be screwed into the bone.Implant placement will be reattempted in 4-6 months.The gemlock driver would just free spin when in use.
 
Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight not provided.Lot number not provided.Manufacturing date is unknown.
 
Manufacturer Narrative
One (1) internal connection universal placement driver tip - long (iipdtul) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was moderate bone density (type ii).The reported device was located on tooth # 30 (universal) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h - 07/2021 -- instructions for use for biomet 3i kits and instruments (p-zbdinstrp) rev.D - sep 2020.Information identified: warnings and precautions.Per the applicable ifu, it is stated that surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling.Care must be taken to avoid compromising their performance.However, dhr review could not be performed for the iipdtul driver as the lot number was unknown.A complaint history review by item number was conducted for the (iipdtul) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (iipdtul).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
 
Event Description
There is no update to the original complaint description provided.
 
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Brand Name
INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
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
susanne taylor
4555 riverside drive
palm beach gardens, FL 33410
5617766700
MDR Report Key12982879
MDR Text Key282097262
Report Number0001038806-2021-02348
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIIPDTUL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/13/2021
Supplement Dates Manufacturer Received05/24/2022
Supplement Dates FDA Received05/27/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexFemale
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