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

Catalog Number	TSV4H10
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the doctor realized that the implant container was empty.Procedure was concluded.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
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 h10: additional narrative zimvie received one (1) tsv4h10, (imp,tsv,4.1mm,dual sel,ha) for evaluation.Visual evaluation of the as returned device identified the implant packaging / outer box was already opened.The outer vial's tamper seal / ring was broken, the inner vial and its contents were missing/not returned.The coob is non-verifiable as the condition of the product when received by the customer is unknown / non-verifiable.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 1264826.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 1264826 for similar events and no other complaint was identified.Review completed utilizing keywords: incorrect component quantity.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is improper handling of devices/packaging outside of zimvie control.Therefore, based on the available information, a packaging malfunction could not be verified.The reported event/coob was non-verifiable since the condition of the product/packaging received by the customer was unknown / 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
No further event information is available at the time of this report.

• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20319706
• Report Number: 0002023141-2024-03090
• Device Sequence Number: 20834519
• Product Code: DZE
• UDI-Device Identifier: 00889024019300
• UDI-Public: (01)00889024019300(17)280408(10)1264826
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2025

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: TSV4H10
• Device Lot Number: 1264826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• 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: 09/27/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic