MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 3MM; HEALING ABUTMENT

Model Number	HC333
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the healing abutment screw is defective, it cannot be screwed.Implant remains placed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One heal collar 3.5x3.5, 3mm (hc333) were returned for investigation.However, the implant was not returned because there is no malfunction with it.Visual evaluation of the as returned products identified some signs of use and wear around the threads.Functional testing to recreate the reported event could be performed by using in-house compatible implant and the abutment threaded normal as its intended.Patient pre-existing condition is unknown due to limited information provided by customer.Tooth location is #14 (fdi).However, the devices were removed same day due to the issue found as reported in the complaint.X-ray or picture image was not provided.Documents reviewed: instructions for use ¿ zimmer dental healing collars, healing screws, surgical cover screws, temporary gingival cuffs, and temporary abutments for use with zimmer dental implant systems, ifu9658 rev 2-10/19.Information identified: indications and warnings (pages 1 & 2) dhr review was completed for the subject lot number 2019050889.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 (2019050889) was performed for similar events and no other similar complaint was identified.Monthly post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (hc333).Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X3.5, 3MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11138885
• Report Number: 0002023141-2021-00050
• Device Sequence Number: 846293
• Product Code: NHA
• UDI-Device Identifier: 00889024014978
• UDI-Public: (01)00889024014978(17)240514(10)2019050889(241)HC333
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 05/14/2024
• Device Model Number: HC333
• Device Catalogue Number: HC333
• Device Lot Number: 2019050889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1