MAUDE Adverse Event Report: ZIMMER DENTAL TSX IMPLANT, 4.1MMD, 16MML; DENTAL IMPLANT

Catalog Number	TSX41B16
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep reported that when the clinician opened one of the implants, they found the implant, mount and cover screw were missing.Product was sealed when opened.The surgical protocol had to be changed but an implant will be placed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.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: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie received the empty implant package for evaluation.Visual evaluation of the as returned device identified the implant packaging's outer vial was already opened.The inner vial and the implant were missing.The outer vial tamper seal / ring was observed broken.The event is non-verifiable as the condition of the packaging when delivered to the customer is unknown / non-verifiable.Dhr review was completed for the subject lot number 1268858.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 1268858 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 is improper handling of devices/packaging outside of zimvie control.Therefore, based on the available information, the packaging malfunction could not be verified.The reported event is non-verifiable as the condition of the product/packaging when 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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: TSX IMPLANT, 4.1MMD, 16MML
• 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 ; 5619713230
• MDR Report Key: 17966786
• Report Number: 0001038806-2023-02019
• Device Sequence Number: 7754343
• Product Code: DZE
• UDI-Device Identifier: 00844868045120
• UDI-Public: (01)00844868045120(17)250613(10)1268858
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2025
• Device Catalogue Number: TSX41B16
• Device Lot Number: 1268858
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2023
• 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: 10/19/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic