MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 5MM; 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	11/17/2021
Type of Reportable Event	Malfunction
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
It was reported that the healing collar is stripped and not sitting well in the implant at tooth location #3.The healing collar was removed.No impact to the patient.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 3331, 4109, 4110, 4111 and 4114.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.One (1) heal collar 4.5x5.5, 5mm (hc455) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.Based on the evaluation, device malfunction could not be verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number (2021041362).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 by lot number (2021041362) was performed for similar events using keyword device malfunction and no other similar complaint was identified.Functional testing to recreate the event could not be performed without the return of the device.A definitive root cause could not be identified.However, the potential cause for the reported event is torque applied during placement/seating exceeds recommended value.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 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: 12982829
• Report Number: 0002023141-2021-03586
• Device Sequence Number: 14770860
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)260506(10)2021041362
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 05/06/2026
• Device Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 2021041362
• 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: 11/24/2021
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 67 KG