MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.7,13,MTX,MC,MG,HA; DENTAL IMPLANT

Catalog Number	TSVMWH13
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reported that cover screw of implant was missing, so that implant could no be placed.Doctor confirmed by phone on (b)(6) 2023 that procedure was completed with a new one.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) tsvmwh13, (imp, tsv, 4.7,13,mtx,mc,mg,ha) for evaluation.Visual evaluation was performed, the returned implant and packaging were identified as reported.The outer vial was observed already opened and the tamper seal / ring was broken.The inner vial was missing the cover screw.He coob is non-verifiable as the conditions of the packaging when delivered to the customer are unknown / non-verifiable.Dhr review was completed for the subject lot number 1219269.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 1219269 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 the operator was not following work instruction.Therefore, based on the available information, a packaging malfunction could not be verified.Without device receipt, the reported coob is non verifiable since the condition of the packaging when delivered to the customer was unknown.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, 4.7,13,MTX,MC,MG,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 ; 5619713230
• MDR Report Key: 17406314
• Report Number: 0002023141-2023-02041
• Device Sequence Number: 5837724
• Product Code: DZE
• UDI-Device Identifier: 00889024344167
• UDI-Public: (01)00889024344167(17)230918(10)1219269
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: Health Professional
• Device Expiration Date: 09/17/2023
• Device Catalogue Number: TSVMWH13
• Device Lot Number: 1219269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic