MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV, 4.1,13, MTX,MC,M; DENTAL IMPLANT

Catalog Number	TSVM4H13
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that during the opening of the packaging, the assistant realizes that the implant was missing.The doctor sends the implant container as it arrived, empty, without the internal product.The procedure was concluded by placing another implant.The affected dental position is unknown.
Additional Manufacturer Narrative
Zimvie received one (1) tsvm4h13, (imp,tsv, 4.1,13, mtx,mc,m) for evaluation.Visual evaluation of the as returned vial identified the vial was already opened, and the tamper seal / ring was broken.The inner vial and associated components were missing.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.Dhr review was completed for the subject lot number 1224377.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 1224377 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿incorrect component quantity¿ the customer did not submit images for the reported event.Ifu review: documents reviewed: instructions for use ¿ tapered screw-vent® and trabecular metal¿ implants - 4869 rev.9-10/19.Information identified: "product packaging" based on the investigation and risk management file review as per rmf rm-00308-pfmea rev.1, 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/coob was non-verifiable since 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.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".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TSV, 4.1,13, MTX,MC,M
• 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: 18149648
• Report Number: 0002023141-2023-03273
• Device Sequence Number: 5788521
• Product Code: DZE
• UDI-Device Identifier: 00889024344013
• UDI-Public: (01)00889024344013(17)241203(10)1224377
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133339
• 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): 05/13/2024

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 Expiration Date: 12/02/2024
• Device Catalogue Number: TSVM4H13
• Device Lot Number: 1224377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• 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: 11/16/2023
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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: Male
• Patient Ethnicity: Non Hispanic