MAUDE Adverse Event Report: ZIMMER DENTAL RETAINING 2.5MM HEX DRIVE R LATCHLOCK; DENTAL DRIVER TOOL

Catalog Number	RHD2.5
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: patient sex unknown / not provided.A4: weight unknown / not provided.B3: date of event unknown / not provided.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a procedure, the driver broke at the tip.The patient is fine and the procedure was completed with another device.
Event or Problem Description
This report is being submitted to retract the initial report, mfr report number 0002023141-2025-02426 that was submitted on september 5, 2025 as this event had already been submitted and is a duplicate of mfr report number 0002023141-2025-02299 that was submitted on august 21, 2025.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the initial report, mfr report number 0002023141-2025-02426 that was submitted on september 5, 2025 is a duplicate of mfr report number 0002023141-2025-02299 that was submitted on august 21, 2025.Therefore, this supplemental mw is being submitted as a retraction due to duplication of mfr report number 0002023141-2025-02299.All details associated with this event will be processed and completed under 0002023141-2025-02299.Therefore, no additional reports will be submitted under mfr report number 0002023141-2025-02426.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: type of investigation codes were added: 4111.H6: investigation findings code was added: 3221 h6: investigation conclusions code was added: 4315.H10: narrative/data was updated.

• Brand Name: RETAINING 2.5MM HEX DRIVE R LATCHLOCK
• Common Device Name: DENTAL DRIVER 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22977347
• Report Number: 0002023141-2025-02426
• Device Sequence Number: 18484444
• Product Code: NDP
• UDI-Device Identifier: 00889024016705
• UDI-Public: (01)00889024016705(17)991231(10)2120012832
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: Other
• Device Catalogue Number: RHD2.5
• Device Lot Number: 2120012832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic