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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX SST 1.25MM 22MM; DENTAL TOOL

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ZIMMER DENTAL TOOL HEX SST 1.25MM 22MM; DENTAL TOOL Back to Search Results
Catalog Number HXL1.25
Device Problem Fracture (1260)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/16/2021
Event Type  Injury  
Event Description
It was reported that screw driver fractured when trying to unscrew the transfer and the tip got inside the transfer, which is why implant had to be removed, as well.Patient has been rescheduled for new implant placement.
 
Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Udi not available.
 
Event Description
No further event information is available at the time of this report.
 
Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One imp,tsv,4.7,10,mtx,mg (tsvtwb10) along with mount and one tool hex sst 1.25mm 22mm (hxl1.25) were returned for investigation.Visual evaluation of the as returned mount identified some body damage most likely due to removal attempt and stuck devices.Additionally, tip of driver identified fractured as well.Functional testing was performed.The mount was stuck in the implant and could not be disengaged.Functional testing for driver could not be performed due to nature of event.Device history record (dhr) review for driver could not be performed without lot information.A year-long complaint history review by item number (hxl1.25) was performed for similar events using keyword functional fracture and no complaint about nonconforming products was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
 
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Brand Name
TOOL HEX SST 1.25MM 22MM
Type of Device
DENTAL TOOL
Manufacturer (Section D)
ZIMMER DENTAL
4555 riverside drive
palm beach gardens FL 33410
Manufacturer (Section G)
ZIMMER DENTAL
4555 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
susanne taylor
4555 riverside drive
palm beach gardens, FL 33410
5617766700
MDR Report Key12802155
MDR Text Key280680820
Report Number0002023141-2021-03243
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
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 02/25/2022
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? No
Device Operator Health Professional
Device Catalogue NumberHXL1.25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/25/2021
Initial Date FDA Received11/12/2021
Supplement Dates Manufacturer Received02/17/2022
Supplement Dates FDA Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
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 Outcome(s) Required Intervention;
Patient Age50 YR
Patient SexFemale
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