MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X6.5, 5MM; DENTAL ABUTMENT

Model Number	HC465
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient identifier: unknown / not provided.Age at time of the event: unknown / not provided.Gender: unknown / not provided.Patient weight: unknown / not provided.Reporter name and address: unknown / not provided.Premarket identification: unknown / not provided.
Event or Problem Description
Healing collar does not engage to the implant.No impact to the patient.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One healing collar (hc465) was reported but not returned for investigation.Therefore, visual evaluation and functional testing could not be performed.Dhr review for the lot (2022070676) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot (2022070676) and no similar event or complaint was found.(complaint category keyword: does not seat).Based on the investigation and risk management file review, and ifu, the most likely root cause determined from the investigation was customer error - improper techniques used during placement.Therefore, based on the available information, device malfunction and the reported event could not be verified.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X6.5, 5MM
• Common Device Name: DENTAL ABUTMENT
• 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 ; 5617766700
• MDR Report Key: 16479824
• Report Number: 0002023141-2023-00708
• Device Sequence Number: 7401094
• Product Code: NHA
• UDI-Device Identifier: 00889024015104
• UDI-Public: (01)00889024015104(17)270715(10)2022070676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111852
• 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): 08/30/2023

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: Other
• Device Model Number: HC465
• Device Catalogue Number: HC465
• Device Lot Number: 2022070676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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