MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,DUAL SEL,HA; DENTAL IMPLANT

Model Number	TSV4H8
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that at the time of the intervention, he realized that the implants were not inside the implant container.The affected dental positions are unknown.The doctor confirms in the per that the procedure was concluded with the placement of another 2 implants.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) empty packaging for a tsv4h8, (imp,tsv,4.1mm,dual sel,ha) for evaluation.Visual evaluation identified the outer box with outer vial returned.Implant inner vial was empty with seal broken.No implant returned.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1252593.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 1252593 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Appropriate documents were reviewed.Information identified: product packaging: all implants have been cleaned, packaged in double vials within an environmentally controlled room, and sterilized for convenience and immediate use.The implants are suspended on a carrier for transfer to the prepared surgical site without risk of contact contamination.Both the implant and the inner vial packaging are sterile.The label on the outer vial packaging for each implant contains a lot number that should be recorded in the patient¿s file to ensure complete traceability of the product.A patient chart label provided containing the lot number can also be placed in the patient file for traceability.Based on the investigation and risk management file review as per rmf rm-00257-pfmea rev.2, the most likely root cause determined from the investigation is improper handling.Therefore, based on the available information, a packaging malfunction could not be verified, and the reported event/coob was non-verifiable since the condition of the product/packaging when received by the customer was unknown.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.
Event or Problem Description
The doctor reports that at the time of the intervention, he realized that the implants were not inside the implant container.The affected dental positions are unknown.The doctor confirms in the per that the procedure was concluded with the placement of another 2 implants.

• Brand Name: IMP,TSV,4.1MM,DUAL SEL,HA
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16640969
• Report Number: 0002023141-2023-00940
• Device Sequence Number: 5245033
• Product Code: DZE
• UDI-Device Identifier: 00889024019348
• UDI-Public: (01)00889024019348(17)270518(10)1252593
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072589
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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 Model Number: TSV4H8
• Device Catalogue Number: TSV4H8
• Device Lot Number: 1252593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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