MAUDE Adverse Event Report: ZIMMER DENTAL TWIST HA 3.25MMX10MM; DENTAL IMPLANT

Catalog Number	2130
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stuck mount.The mount won't come off.The doctor said that implant was defective because the mount did not loosen before the operation.He used a different implant.The doctor hopes for an improvement and an investigation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie did not receive one (1) 2130, (twist ha 3.25mmx10mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 2021080073.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 2021080073 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-002j2, the most likely root cause determined from the investigation was clinician uses device improperly, insufficient training.Therefore, based on the available information, a device malfunction was not verified.Without device receipt, the reported event is 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.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h3: changed "yes" to "no" h6: entered evaluation codes h10: added manufacturer narrative h3 other text : device was not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TWIST HA 3.25MMX10MM
• Common Device Name: DENTAL IMPLANT
• 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: 20426175
• Report Number: 0002023141-2024-03252
• Device Sequence Number: 8441301
• Product Code: DZE
• UDI-Device Identifier: 00889024013285
• UDI-Public: (01)00889024013285(17)270406(10)2021080073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093164
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2025

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: 2130
• Device Lot Number: 2021080073
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic