MAUDE Adverse Event Report: PALISADES DENTAL, LLC IMPACT AIR 45; HANDPIECE

Model Number 403

Device Problems Misassembled (1398); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265); Misassembly During Maintenance/Repair (4054)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Palisades dental, llc was notified on (b)(6) 2019 by a (b)(6) representative that an incident occurred on (b)(6) 2019 involving the use of an impact air 45® handpiece, serial # (b)(4), in which a patient swallowed a bur that dislodged from the handpiece.As part of palisades dental's investigation, a review of palisades dental sales records confirmed the sale of handpiece # (b)(4) on (b)(6) 2014 to (b)(6).Records further indicate that the handpiece has not been at palisades dental for service since it was originally sold.A review of manufacturing records for # (b)(4) did not find any abnormalities with the batch records or associated documentation.On (b)(4) 2019 a palisades dental representative spoke with the (b)(6) pro repair manager, who communicated with the dentist involved in the reported incident.The (b)(6) pro repair manager was also the individual involved with the evaluation and repair of the handpiece.(b)(6) pro repair reported that the turbine installed in the handpiece was a "turbine rebuild with ceramic bearings" which was installed into the handpiece a few months earlier by pro repair.It was further reported that when re-evaluating the turbine after the alleged incident it was found that the chuck teeth were broken, the turbine was not lubricated, and it was also very dirty.The (b)(6) pro repair manager cited that the incident was "operator error" as the dentist and his staff did not clean and maintain the turbine properly and that the turbine was the issue in this incident, not the handpiece.(b)(6) pro repair replaced the turbine, discussed the importance of proper maintenance of the handpiece with the dentist, and sent the handpiece back to the dentist's office.(b)(6) pro repair retained the turbine and head cap parts that were installed in the handpiece at the time of the incident.The handpiece was not sent to palisades dental for evaluation after the alleged incident.Palisades dental requested the retained turbine and head cap parts from (b)(6) pro repair for evaluation.Palisades dental received turbine and head cap parts on 03/15/19.Palisades dental's evaluation determined the following: the turbine assembly is not a palisades dental manufactured part (nor are any of the individual components that make up the turbine assembly).The turbine assembly was dirty.On (b)(4) 2019 a palisades dental representative spoke with the dentist involved in the reported incident.The dentist confirmed that the incident took place on (b)(6) 2019 and that the bur dislodged from the handpiece while in use and it was subsequently swallowed by the patient, but he indicated that the patient was a male, not a female as stated in the (b)(6) adverse event form.The palisades dental representative asked the dentist for confirmation that "the patient was not injured and did not seek medical attention" as stated in the (b)(6) adverse event form.The dentist indicated that this information is not accurate.The dentist reported that after the patient swallowed the bur, he went to the emergency room for a chest x-ray to see if he aspirated the bur.The x-ray confirmed that the patient did not aspirate the bur and no further medical treatment was deemed necessary.Palisades dental made several attempts to the dentist's office to request the return of the impact air 45 handpiece (post repair by (b)(6) pro repair) to palisades dental for evaluation, but the handpiece has not been returned as the date of this report.Based on the information gathered during the investigation, palisades dental has concluded that the failure is not manufacture related, rather it is related to service and maintenance that does not comply with palisades dental product labeling.

Event Description

Palisades dental was notified via email from (b)(6) on (b)(6) 2019 that a patient swallowed a bur dislodged from an impact air 45 handpiece on (b)(6) 2019.As per the ((b)(6) pro repair) handpiece repair manager, the turbine in the handpiece was not properly maintained causing the bur to dislodge.The handpiece repair manager went over maintenance with the doctor.The patient was not injured and did not seek medical attention.The handpiece has been repaired (by (b)(6) pro repair) and was shipped back to the dentist's office.

• Brand Name: IMPACT AIR 45
• Type of Device: HANDPIECE
• Manufacturer (Section D): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer (Section G): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer Contact: maureen mcgovern ; 111 cedar lane; englewood, NJ 07631 ; 2015690050
• MDR Report Key: 8465343
• MDR Text Key: 146235249
• Report Number: 3003963943-2019-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 403
• Device Lot Number: 7002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other