MAUDE Adverse Event Report: ZIMMER DENTAL ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM; DENTAL ABUTMENT

Model Number	TAC2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age at time of the event unknown / not provided.Weight unknown / not provided.Additional device information unknown / not provided.Premarket identification k013227.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that the abutment screws fractured at tooth location 46.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One abut tapered one-piece scr-v 3.5mm 2mm, tac2 was returned for investigation.Visual inspection via naked eye and camera magnification was completed.Fracture was identified at the screw threads of the abutment.Device history record (dhr) review was completed for the subject lot number (64090522).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (64090522) for similar event (complaint category keywords: fracture screw) and revealed no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Based on the available information, 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: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14101314
• Report Number: 0002023141-2022-00904
• Device Sequence Number: 20404533
• Product Code: DZE
• UDI-Device Identifier: 00889024018419
• UDI-Public: (01)00889024018419(17)230630(10)64090522
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K011028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: TAC2
• Device Catalogue Number: TAC2
• Device Lot Number: 64090522
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2018
• 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 Sex: Female