MAUDE Adverse Event Report: ZIMMER DENTAL 1.25 HEX TL,GEMLOCK RETEN; DENTAL DRIVER

Catalog Number	HXGR1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a1: patient identifier unknown / not provided a2: age and date of birth unknown / not provided a3: gender unknown / not provided a4: patient weight unknown / not provided b3: date of event unknown / not provided d4: lot/serial # unknown / not provided d4: device expiration date unknown / not provided d4: device udi number unknown / not provided e1: first name unknown / not provided e1: last name unknown / not provided h4: device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that hex driver hxgr1.25 broke when trying to remove the fixture mount.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report d4: lot/serial # d4: device udi number d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h4: device manufacturer date h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) hxgr1.25, (1.25 hex tl,gemlock reten) for evaluation.Visual evaluation of the as returned device identified the driver with signs of use.The driver's tip was observed bent and fractured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120000538.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 2120000538 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rmf rm-002w1 rev.8, the most likely root cause determined from the investigation is the use of incorrect techniques during procedure.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.The following sections have been updated: b4: date of this report, g3: date received by manufacturer, g6: checked "follow-up," h2: checked follow-up type, h3: changed "no" to "yes," h6: entered evaluation codes, h10: added manufacturer narrative.

• Brand Name: 1.25 HEX TL,GEMLOCK RETEN
• 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: 20158014
• Report Number: 0002023141-2024-02859
• Device Sequence Number: 14512333
• Product Code: NDP
• UDI-Device Identifier: 00889024015418
• UDI-Public: (01)00889024015418(17)991231(10)2120000538
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 01/15/2025

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: Lay User/Patient
• Device Catalogue Number: HXGR1.25
• Device Lot Number: 2120000538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/13/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic