MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X5.5, 5MM; DENTAL HEALING ABUTMENT

Model Number	HC355
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that when placing th healing abutment screws, it was impossible to screw them.The cover screws and the mount screwed perfectly into the implants, but not the healing abutment screws.Implants remain in patient's mouth.
Event or Problem Description
No further event information is available at the time of the report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Two heal collars 3.5x4.5, 5mm (hc345 x 2) and one heal collar 3.5x5.5, 5mm (hc355) were returned for investigation.Visual evaluation of the as returned products identified damaged threads on all three devices.Functional testing was not performed due to the nature of the devices and event.Due to the thread damage, the products could not seat.Device history record (dhr) review for the lots (2022010903 & 2020110057) 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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2022010903 & 2020110057) for similar events (complaint category keywords: does not seat) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: HEAL COLLAR 3.5X5.5, 5MM
• Common Device Name: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13891220
• Report Number: 0002023141-2022-00709
• Device Sequence Number: 1779929
• Product Code: NHA
• UDI-Device Identifier: 00889024015036
• UDI-Public: (01)00889024015036(17)251104(10)2020110057
• 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): 08/01/2022

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: 11/04/2025
• Device Model Number: HC355
• Device Catalogue Number: HC355
• Device Lot Number: 2020110057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female