MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 7MM; DENTAL ABUTMENT

Model Number	HC455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healing collar cannot be placed even if it is attached to the implant.It will rotate and cannot be tightened.Tooth site # 14.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Upon evaluation and customer follow up, the item number was updated.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the catalog number and lot number were updated/corrected.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D1: brand name was updated.D4: catalog number, lot number, udi number and expiration date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was updated.H10: narrative/data was updated.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 180.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported healing collar for evaluation.Visual evaluation and a functional test was performed, there was signs of use.The healing collars threads were discolored and damaged.It would not seat with an in-house implant.Dhr review was completed for the subject lot number 2021111306.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 2021111306 for similar events and no other complaint was identified.The customer did submit images for the reported event.The device was not inside its original packaging.The healing collars threads were discolored.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, device malfunction did occur.The healing collars threads were discolored and damaged.It would not seat with an in-house implant.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 7MM
• 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: 17286610
• Report Number: 0002023141-2023-01835
• Device Sequence Number: 2985181
• Product Code: NHA
• UDI-Device Identifier: 00889024015081
• UDI-Public: (01)00889024015081(17)261126(10)2021111306
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: HC455
• Device Catalogue Number: HC457
• Device Lot Number: 2021111306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 11/27/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic