MAUDE Adverse Event Report: ZIMVIE US CORP LLC RETAINING 2.5MM HEX DRIVE R LATCHLOCK; DENTAL DRIVER

Catalog Number	RHD2.5
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the latchlock driver fractured at the tip during the implant placement.No impact on the patient reported.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h11: additional narrative.Additional information was obtained on 18-may-2026 regarding the inspection findings.The clinician does not recall the case.Information is not available.Zimvie received one (1) rhd2.5, (retaining 2.5mm hex drive r latchlock) for evaluation.Visual evaluation was performed, the driver has signs of use, wear.The driver was not fractured.Additionally, the driver¿s iso latch was damaged from use.During a functional test, the driver wouldn¿t engage with an ion-house handpiece.The driver was also missing the ruby ball.Dhr review was completed for the subject lot number 2021120798.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 2021120798 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : fracture and dental : functional : device malfunction¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The driver¿s iso latch was not fractured, the iso was damaged.Additionally, the driver¿s retention ball was missing.The reported fractured event was non-verifiable.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
It was reported that the latchlock driver fractured at the tip during the implant placement.No impact on the patient reported.Upon investigation it was found that the driver¿s iso latch was damaged and wouldn't assemble.

• Brand Name: RETAINING 2.5MM HEX DRIVE R LATCHLOCK
• Common Device Name: DENTAL DRIVER
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24843175
• Report Number: 0001038806-2026-01935
• Device Sequence Number: 8946493
• Product Code: NDP
• UDI-Device Identifier: 00889024016705
• UDI-Public: (01)00889024016705(17)991231(10)2021120798
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: Other
• Device Catalogue Number: RHD2.5
• Device Lot Number: 2021120798
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/24/2026
• 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: 04/10/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic