MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X4.5, 5MM; HEALING ABUTMENT

Model Number	HC445
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Age: not provided.Patient weight: not provided.
Event or Problem Description
It was reported that healing abutment was unable to be screwed.No impact to the patient reported.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) the following fields have been updated: a1: patient identifier unknown b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one heal collar 4.5x4.5, 5mm (hc445) was returned for investigation.Visual evaluation of the as returned product identified that the threads were damaged.Functional testing was performed and the device failed to function properly as the threads were damaged.Device history record (dhr) review for the lot (2019030803) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019030803) for similar events (complaint category keywords: does not seat) and no other complaint was identified.Therefore, based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X4.5, 5MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12112057
• Report Number: 0002023141-2021-01699
• Device Sequence Number: 19846533
• Product Code: NHA
• UDI-Device Identifier: 00889024015050
• UDI-Public: (01)00889024015050(17)240312(10)2019030803
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 03/12/2024
• Device Model Number: HC445
• Device Catalogue Number: HC445
• Device Lot Number: 2019030803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1