MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROMARK ENDO MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number	PMKEM1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported a aseptico promark endo motor was running slow and erratic during use.No injury.
Additional Manufacturer Narrative
Evaluation performed by aseptico.See attached report.Closing comments: *pack* power bd fail, eval only.Failure mode - speed incorrect/too fast/too slow.Root cause - miscellaneous electronic problem (ready for download, does not turn on, etc.) conclusion code - unexpected failure.
Additional Manufacturer Narrative
Additional information received that incorrect investigation was sent and noted for this complaint.Investigation was for another complaint.Aseptico indicated there is no record of a repair for pearl st dental¿s promark.Therefore, disregard the investigation results that were previously submitted 1/15/2025.This is a follow up report for this additional information that was received.

• Brand Name: PROMARK ENDO MOTOR
• Common Device Name: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20677639
• Report Number: 2320721-2024-00069
• Device Sequence Number: 18235263
• Product Code: EKX
• UDI-Device Identifier: D716PMKEM11
• UDI-Public: D716PMKEM11
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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
• Device Catalogue Number: PMKEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/15/2025; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown