MAUDE Adverse Event Report: ZIMMER DENTAL DRILL 1.25MM HEX SST; DENTAL DRIVER

Catalog Number	HX1.25D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported, the tip of the driver snapped off.And driver bent and twisted as well as fractured.Procedure was not completed.They were able to successfully remove 3 of the abutments, but one they were not.No damage to abutment.Will complete procedure, once they receive replacement driver.
Additional Manufacturer Narrative
Zimvie received one (1) hx1.25d, (drill 1.25mm hex sst) for evaluation.Visual evaluation was performed, slight wear and tip is twisted/bent and fractured.Dhr review was completed for the subject lot number 2120001415.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120001415 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : bent and dental : functional : fracture.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation was clinician error and excessive torque lead to a fractured, twisted or bent tool.Damage in tool connection.Therefore, based on the available information, a device malfunction did occur.The tool has wear and tip is twisted/bent and fractured.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: DRILL 1.25MM HEX SST
• Common Device Name: DENTAL DRIVER
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19620808
• Report Number: 0002023141-2024-02151
• Device Sequence Number: 6520271
• Product Code: NDP
• UDI-Device Identifier: 00889024015388
• UDI-Public: (01)00889024015388(17)991231(10)2120001415
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: HX1.25D
• Device Lot Number: 2120001415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic