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

Model Number 403 (FOR BOTH SERIAL NUMBERS)

Device Problems Device Maintenance Issue (1379); Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

On 04/13/2017, palisades dental, llc was notified by (b)(4) of an incident that reportedly involved the use of an impact air 45® handpiece #(b)(4) while a dentist was performing a procedure on a (b)(6) year old male patient at the (b)(6) on (b)(6) 2017.It was reported that as the dentist was sectioning tooth #14 when the burr came out of the handpiece.It was reported that he burr came out of the handpiece when he saw that the burr had made its way to the back of the patient's throat then eventually the patient had swallowed it.It was reported that on (b)(6) 2017 the burr had to be removed via endoscopic procedure at the hospital.As part of our investigation, on 04/14/2017 a representative of palisades dental, llc spoke with the dentist and a dental assistant of (b)(6) to discuss details related to the incident.When asked about the condition of the patient, the dentist indicated that the patient is doing well.When asked about maintenance of the handpiece, the dentist responded that he thinks that they just lube it, but he indicated that his assistant maintains the equipment.His dental assistant told the palisades dental, llc representative that after each use they put two drops of lubricant into the intake tube, flush it and autoclave it.The dentist indicated that they use surgical fg 557 burs, which his assistant puts in, and that prior to a procedure, both he and his assistant try to pull out the burs, without touching the button.The dental assistant informed the palisades dental, llc representative that only one handpiece was in the room and used during the procedure.After the incident, the handpiece was sent to the sterilization room, but it was autoclaved with another impact air 45 handpiece; as a result, making it impossible to ascertain which of the two handpieces was used during the procedure.The dental assistant reported that handpiece #(b)(4) was last serviced on 2/9/2017 and handpiece #(b)(4) was last serviced on 1/25/2017 by handpiece headquarters (a division of (b)(4)).She indicated that both handpieces had a rebuild and chuck.According to the dentist, neither handpiece was used again after the adverse event and that they were pulled from circulation and sent to aspen dental's corporate office.On 04/21/2017, palisades dental, llc received sus voluntary event report #mw5068877 from the fda which relates to this adverse event.On 04/27/2017, handpiece/s #(b)(4) were both received at palisades dental at the end of the business day.On 04/28/2017, palisades dental completed an evaluation of handpieces #(b)(4) and associated records.Our investigation revealed that handpieces #(b)(4) were sold to (b)(4) on 11/03/2010 and neither handpiece # (b)(4) had ever been sent to palisades dental for service or evaluation prior to the adverse event.A review of the manufacturing records for #(b)(4) did not find any abnormalities with the batch record or associated documentation.Our findings revealed that non-palisades dental parts were installed in both handpieces and the assembly configuration was not in accordance with palisades dental's specifications.Palisades dental has determined that the failure is not manufacturer related, rather it is related to service and maintenance performed by facilities other than those specified in product labeling (i.E.Facilities other than palisades dental).Since the end user is unable to identify which one of the two handpieces was used and it was confirmed by the end user that only one handpiece was used in the procedure, it is impossible for palisades dental's investigation to conclude which factor or device contributed to the failure.

Event Description

It was reported that as the dentist was sectioning a tooth the burr came out of the handpiece and was swallowed by the patient.It was reported that the dentist was using impact air 45 handpiece, either serial #(b)(4).It was reported that the burr had to be removed via endoscopic procedure at the hospital.Palisades dental, llc received sus voluntary event report #mw5068877 from fda.

• 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): MAUREEN MCGOVERN; 111 cedar lane; englewood NJ 07631
• Manufacturer Contact: maureen mcgovern ; 111 cedar lane; englewood, NJ 07631 ; 2015690050
• MDR Report Key: 6553472
• MDR Text Key: 74740919
• Report Number: 3003963943-2017-00001
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 403 (FOR BOTH SERIAL NUMBERS)
• Device Lot Number: 5957 (FOR BOTH SERIAL NUMBERS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR