MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 5MM; DENTAL HEALING ABUTMENT

Model Number	HC455
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that unable to screw the healing collar completely into the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the product experience report.The reported device tooth location and length of implantation of use is unknown.Pictures or x-ray images were not provided.Device history record review was completed for the subject lot number (2019031008).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019031008) for similar event and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).A heal collar 3.5x5.5, 5mm (hc455) was returned for investigation, see attached images a067-a069 in the complaint.Visual evaluation of the as returned product identified worn markings due to usage and a wear around threads, as well as debris.Functional testing was performed for the returned product with an in-house stock device and assembled as intended.No malfunction was identified.No pre-existing conditions were noted on the per.The reported device tooth location and length of implantation of use is unknown.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (2019031008).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019031008) for similar event and no other complaint was identified.June post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: DENTAL HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9933371
• Report Number: 0002023141-2020-00720
• Device Sequence Number: 17067922
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)240314(10)2019031008(241)HC455
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2020

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: 03/14/2024
• Device Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 2019031008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 05/29/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 06/04/2020; 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1