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

Catalog Number	HC343
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Problem of screwing into the implant during placement.Procedure completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products hc343, heal collar 3.5x4.5, 3mm lot 2120000759.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative zimvie received one (1) hc343, (heal collar 3.5x4.5, 3mm) for evaluation.Visual evaluation was performed, there was signs of use, the abutments threads were damaged.A functional test could not be completed due to the damage to the threads.Dhr review was completed for the subject lot number 2022031267.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 2022031267 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : does not seat.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The healing collar was used and had damaged threads.Unable to perform a functional test.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.
Event or Problem Description
No further event information is available at the time of this 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19769722
• Report Number: 0002023141-2024-02416
• Device Sequence Number: 8576050
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)270323(10)2022031267
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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 Catalogue Number: HC343
• Device Lot Number: 2022031267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• 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: 07/18/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE; DENTAL ABUTMENT SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic