MAUDE Adverse Event Report: ZIMMER DENTAL 4.0 MM NARROW TEMPORARY G INGIVAL CUFF 3 MM CUFF; DENTAL HEALING ABUTMENT

Catalog Number	1949
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
It was reported that the gingival cuff (1949) could not be attached to the implant body.The doctor said that the male thread was not properly threaded, which may have caused a defective product.Completed with another identical product.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: unique identifier (udi) number.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie did not receive one healing abutment 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.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 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation were missing or confusing instructions for use and torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction could not be verified.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.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 10.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.H10: narrative/data was updated.Zimvie received the reported abutment for evaluation.Visual evaluation was performed, slight damage to threads.Functionally tested in-house implant and engages, retains and disengages as intended but with force.Even though there is wear on the threads due to the usage of the product no malfunction was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, device malfunction did not occur.Wear/damage to threads due to usage however product was able to be seated with in-house implant.The reported event is unconfirmed.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.
Event or Problem Description
The reported device was returned and evaluated.

• Brand Name: 4.0 MM NARROW TEMPORARY G INGIVAL CUFF 3 MM CUFF
• Common Device Name: DENTAL HEALING ABUTMENT
• 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 ; 45; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19700736
• Report Number: 0002023141-2024-02285
• Device Sequence Number: 3616168
• Product Code: DZE
• UDI-Device Identifier: 00889024012974
• UDI-Public: (01)00889024012974(17)991231(10)2022101161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001786
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2025

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: Health Professional
• Device Catalogue Number: 1949
• Device Lot Number: 2022101161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 11/19/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic