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

Catalog Number	HC345
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).B3: date of event unknown / not provided.
Event or Problem Description
Doctor reported that screw does not fit in implant.
Additional Manufacturer Narrative
Zimvie received one (1) hc345, (heal collar 3.5x4.5, 5mm) for evaluation.Visual evaluation and a functional test was performed, the abutments threads were discolored.However, the abutment seated with an in-house implant as intended.Dhr review was completed for the subject lot number 2023050229.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 2023050229 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : fit : does not seat¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was the clinician damages screw surface (e.G.Scratches, dents resulting in removal of screw material).However, product evaluation concluded that the device was working within specifications.Therefore, based on the available information, a device malfunction did not occur.The healing collar seated with an in-house implant as intended.The reported event was not 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 available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Common Device Name: HEALING COLLAR
• 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: 18140669
• Report Number: 0002023141-2023-03245
• Device Sequence Number: 17789196
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)280505(10)2023050229
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: HC345
• Device Lot Number: 2023050229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/15/2023
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic