MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X4.5, 3MM; HEALING ABUTMENT

Model Number	HC443
Medical Device Problem Codes	Positioning Failure (1158); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(6).Patient identifier is not provided / unknown.Patient age is not provided / unknown.Patient weight is not provided / unknown.
Event or Problem Description
It is reported that the screw would not engage, seems bent or at an angle.Another device was used to complete the procedure.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The healing collar was returned.The reported event was confirmed following visual evaluation and functional testing.Based on the evaluation, healing collar malfunction has occurred.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 actionable events or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the products were within specifications and conforming when they left zimvie.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Functional testing was performed using an applicable in-house implant.The device could not be threaded fully into the implant due to thread damage.Therefore, the reported event was recreated.The complaint is related to the functional performance of the device.A definitive root cause could not be determined.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.

• Brand Name: HEAL COLLAR 4.5X4.5, 3MM
• Common Device Name: 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: 14462583
• Report Number: 0002023141-2022-01268
• Device Sequence Number: 4515373
• Product Code: NHA
• UDI-Device Identifier: 00889024015043
• UDI-Public: (01)00889024015043(17)260426(10)2021040725
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 04/26/2026
• Device Model Number: HC443
• Device Catalogue Number: HC443
• Device Lot Number: 2021040725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose