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

Model Number	HC445
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).  patient weight unknown / not provided.
Event or Problem Description
Customer reported after uncovering the implant tried to place healing collar 4.5mmx5mm.Healing collar would not thread to the implant.Procedure was completed using another healing collar.Tooth location not reported.
Additional Manufacturer Narrative
One (1) heal collar 4.5x4.5, 5mm (hc445) was returned for investigation.Visual evaluation of the as returned product identified damage threads.Does not thread into in-house product as intended.Malfunction.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site (universal) and was used, placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2020100689).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, were 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 (2020100689) for similar events and no other complaint was identified.Aug post market trending was reviewed and there were no actionable events or corrective actions for the reported events.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did occur and the reported events were confirmed.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X4.5, 5MM
• Common Device Name: HEALING COLLAR
• 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: 14192928
• Report Number: 0002023141-2022-00991
• Device Sequence Number: 19945106
• Product Code: NHA
• UDI-Device Identifier: 00889024015050
• UDI-Public: (01)00889024015050(17)251020(10)2020100689
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 10/20/2025
• Device Model Number: HC445
• Device Catalogue Number: HC445
• Device Lot Number: 2020100689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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: 57 YR
• Patient Sex: Female