MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM; DENTAL IMPLANT

Catalog Number	TSV6B11
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A1: patient identifier is not provided / unknown.A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.B3: date of event is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.G4: additional 510(k) number is k013227.
Event or Problem Description
It was reported via email that the customer recived an implant without an implant in packaging vial.No reported impact to patient.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie did not receive one (1) tsv6b11, (impl tapered scr-v mtx 6m m 5.7mm 11.5mm) 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).The customer did submit images for the reported event.The cap tampered seal seem to be broken.Coob is non-verifiable as the conditions of the product / packaging when delivered to the customer are unknown.Dhr review was completed for the subject lot number 1274710.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 1274710 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : packaging : incorrect component quantity based on the investigation and risk management file review, the most likely root cause determined from the investigation was improper handling of product outside of zimvie controls.Therefore, based on the available information, a device malfunction could not be verified.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: IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM
• 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: 19959584
• Report Number: 0002023141-2024-02664
• Device Sequence Number: 7080136
• Product Code: DZE
• UDI-Device Identifier: 00889024019386
• UDI-Public: (01)00889024019386(17)281105(10)1274710
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Catalogue Number: TSV6B11
• Device Lot Number: 1274710
• Was Device Available for Evaluation?: No
• 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: 08/12/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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