MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X5.5, 3MM

Catalog Number	HC353
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that gingiva former could not screw properly, threads could be damaged.Procedure was completed with a new device.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) hc353, (heal collar 3.5x5.5, 3mm) for evaluation.Visual evaluation and a functional test was performed, the threads were damaged.The abutment could not be threaded with in-house implant.Dhr review was completed for the subject lot number 2021121019.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 2021121019 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: fit: does not seat.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use or the clinician damages screw surface (e.G.Scratches, dents resulting in removal of screw material).Therefore, based on the available information, a device malfunction did occur.There was thread damage, the abutment wouldn¿t engage with an in-house implant.The reported event was confirmed.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.

• Brand Name: HEAL COLLAR 3.5X5.5, 3MM
• Common Device Name: HEAL COLLAR
• 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: 17604453
• Report Number: 0002023141-2023-02341
• Device Sequence Number: 6138942
• Product Code: NHA
• UDI-Device Identifier: 00889024015029
• UDI-Public: (01)00889024015029(17)261202(10)2021120055
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2024

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: Lay User/Patient
• Device Catalogue Number: HC353
• Device Lot Number: 2021120055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2023
• 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: 08/23/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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