MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 3MM; HEALING ABUTMENT

Catalog Number	HC453
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).E1: email unknown / not provided.
Event or Problem Description
It was reported that the doctor had a hard time removing the healing collar and once it was removed there was damage to the internal implant and healing collar was also stripped in the processed.The implant was internally damaged and the healing collar were stripped because the doctor had a hard time removing the healing collar during clinical procedure.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Additional information was obtained on 14-mar-2024.The clinician experienced a difficulty removing the healing collar (hc).Once removed there was damage to the implants internals and the hc were stripped.Zimvie received one (1) hc453, (heal collar 4.5x5.5, 3mm) for evaluation.Visual evaluation was performed, there was signs of use.Damage to the threads was identified.The threads were also discolored.Dhr review was completed for the subject lot number 2020120032.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 2020120032 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation was the torque applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The abutment threads were damaged.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.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.

• Brand Name: HEAL COLLAR 4.5X5.5, 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18939202
• Report Number: 0002023141-2024-00815
• Device Sequence Number: 12523357
• Product Code: NHA
• UDI-Device Identifier: 00889024015067
• UDI-Public: (01)00889024015067(17)251203(10)2020120032
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2025
• Device Catalogue Number: HC453
• Device Lot Number: 2020120032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic