MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 3MM; DENTAL HEALING ABUTMENT

Catalog Number	HC333
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
Doctor reported that abutment does not screw during placement at tooth site 35.Patient has been rescheduled for new abutment placement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) hc333, (heal collar 3.5x3.5, 3mm) for evaluation.A visual evaluation and functional test were performed, signs of use was identified.The abutment threads were damaged and discolored.The abutment wouldn¿t thread into an in-house implant.Dhr review was completed for the subject lot number 2023020277.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 2023020277 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 and 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X3.5, 3MM
• Common Device Name: DENTAL HEALING 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: 17116307
• Report Number: 0002023141-2023-01664
• Device Sequence Number: 6612054
• Product Code: NHA
• UDI-Device Identifier: 00889024014978
• UDI-Public: (01)00889024014978(17)280206(10)2023020277
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/02/2023

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 Catalogue Number: HC333
• Device Lot Number: 2023020277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2023
• 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 Age: 45 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic