MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; DENTAL ABUTMENT

Model Number	HC343
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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 (abutment) on implant tooth site #20 would not screw into place.Another healing collar was used.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received the subject for evaluation.Visual evaluation was performed, and the threads have damage.Testing with in-house implant shows that the collar can not be threaded in.Malfunction.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : does not seat.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction did occur.The collar can not be threaded in the in-house implant.The reported event was confirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• 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: 16748130
• Report Number: 0002023141-2023-01063
• Device Sequence Number: 3379407
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)261122(10)2021111008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111852
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2021111008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 71 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic