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

Model Number 403

Device Problems Device Maintenance Issue (1379); Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Palisades dental, llc was notified by (b)(6) on (b)(6) 2015 of an incident that reportedly involved the use of an impact air 45® handpiece # (b)(4) while a dentist at (b)(6), was performing a procedure on a patient at the (b)(6) office.Upon receipt of this information we requested that said handpiece be sent to us by (b)(6) for investigation, evaluation and repair or replacement.As part of our investigation on (b)(4) 2015, a representative of palisades dental, llc spoke with a representative of (b)(6) to discuss details related to the incident.We were informed that during a tooth extraction procedure using handpiece (b)(4), the bur disengaged from the handpiece and an x-ray later revealed that the bur was in the patient's sinus cavity.We also were told that this handpiece had recently been serviced by handpiece headquarters (an affiliate of (b)(6)) because the bur was not holding.Furthermore, we were informed by (b)(6) that the repair person at handpiece headquarters indicated that the handpiece might have been dropped.Additionally, (b)(6) explained that during the last repair on or about september 18, 2015 the repair person at handpiece headquarters had adjusted the chuck/turbine in an effort to service the unit.Upon receipt of handpiece #(b)(4) at our facility, palisades dental, llc completed an evaluation of the handpiece and associated records.Palisades dental, llc did not find any abnormalities with the batch record or associated documentation.When examining the handpiece we did find a thin teflon washer was missing, the black o-ring was torn, the spindle was pushed out of position and the water line was slightly bent.It is our determination that although some of these characteristics are consistent with a handpiece that has been dropped, these issues may also be attributed to improper installation or adjustment of the turbine by an outside facility that performed the repair; therefore, either or both of these conditions could have contributed to the bur disengaging.Our investigation revealed that handpiece (b)(4) was purchased by (b)(6) in (b)(6) 2010 and the unit was sent to palisades dental by (b)(6) once for service in may, 2010 for an unrelated matter.Palisades dental has not serviced this unit since 2010; therefore, palisades dental has determined that this matter is not manufacturer related, rather it is either related to improper handling by customer or it is repair related due to ongoing repair, service and maintenance performed by facilities other than those specified in product labeling (i.E.Facilities other than palisades dental).During a follow-up call made to (b)(6) on october 22, 2015, palisades dental, llc was told that the patient has no future appointments scheduled with (b)(6) and is possibly seeking treatment with an ent.(b)(6) indicated that they will attempt to keep in contact with the patient to follow-up on his condition and treatment and will keep palisades dental updated accordingly.Handpiece # (b)(4) will be retained by palisades dental, llc and our investigation is ongoing.To avoid further inconvenience to the customer, a new impact air 45® handpiece was sent to (b)(6) on october 23, 2015, together with a care and use manual.(b)(6) has been advised to review the servicing information of the manual as well as the cleaning procedure to help insure that the impact air 45® handpiece performs optimally.

Event Description

It was reported that during a tooth extraction procedure using impact air 45 handpiece (b)(4), the bur disengaged from the handpiece and an x-ray later revealed that the bur was in the patient's sinus cavity.

• Brand Name: IMPACT AIR 45
• Type of Device: DENTAL 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: 5211171
• MDR Text Key: 30780961
• Report Number: 3003963943-2015-00002
• 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: distributor,user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2009
• 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): Required Intervention