MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 5MM; ABUTMENT

Model Number	HC345
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the thread of the healing collar were off and therefore it would not seat in the implant.Procedure was completed with a new healing collar.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) heal collar 3.5x4.5, 5mm (hc345) was returned for investigation.Visual evaluation of the as returned product identified no obvious signs of deviations.However, when tried into stock tsv the threads would not engage.Functional testing was not performed due to the nature of the device and event.The product could not seat.Therefore, the reported event was recreated.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site (universal).The customer did not provide any pictures or x-rays.Review of appropriate documentation: 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: per the applicable ifu, improper techniques and overloading may lead to device failure.Dhr review: dhr review was completed for the subject lot number (2020070136).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: complaint history review was performed for the reported lot number (2020070136) for similar events and one (1) other complaint was identified ((b)(4)).Review completed utilizing keywords: does not seat post market trending review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (hc345).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.Sections updated: g3: date investigation results were received.

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Common Device Name: 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: 13902347
• Report Number: 0002023141-2022-00720
• Device Sequence Number: 17611598
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250713(10)2020070136
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 07/13/2025
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2020070136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose