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); Improper or Incorrect Procedure or Method (2017); Lack of Maintenance Documentation or Guidelines (2971); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

On 9/27/2017, palisades dental llc was notified by (b)(6) of an event that reportedly involved the use of an impact air 45 handpiece, (b)(4).The initial report stated, "the customer reports that as they were performing a crown and bridge procedure, diamond crown and bridge burs would not stay in the handpiece.As a result, it would come off in the patient's mouth.They were able to retrieve the burs and no patient was harmed.It happened with two different handpieces.The specifics of the patient was not provided.As part of palisades dental's investigation, on 10/10/2017 a representative of palisades dental, llc spoke with the dentist who performed the procedure related to the alleged event.The dentist stated that while "working on a tooth doing a crown prep one of the diamond burs shot out, the bur was caught by the suction and found in the filter".It was confirmed by the dentist that, "only one handpiece was involved in the event." neither the dentist nor the staff could identify which of the two handpieces was involved; therefore, they sent both to be checked.The dentist further confirmed that no injury was sustained by the male patient who was approximately (b)(6) according to the dentist.The dentist stated that the patient was notified of what happened and was told that the bur was found.The dentist stated that to the best of her knowledge the patient is fine.When asked about the maintenance of the handpieces, the dentist that the handpiece had been sent out for service previously about 1 or 2 months ago because the bur was coming out.The dentist reported that the repair facility told the dental practice that there was no problem found.It was confirmed by the office manager of the dental practice that all handpieces are sent to (b)(6) for service.The dentist did not know what maintenance procedure is used on the handpiece.The dentist stated that she inserted the bur and pulled on it to check it before it as used.On 10/06/2017, handpieces (b)(4) were received at palisades dental at the end of the business day.On 10/09/2017 palisades dental completed an evaluation on (b)(4) and associated records.It is noted that both handpieces were sold to (b)(6).The (b)(4) was sold on 5/8/2015 and (b)(4) was sold on 03/22/2016 and that neither handpiece had ever been sent to palisades dental for service or evaluation.A review of the manufacturing records for (b)(4) did not find any abnormalities with the batch records or associated documentation.Palisades dental deems no corrective action is needed since palisades dental has determined that the failure is not manufacturer related, rather it is related to lack of routine maintenance, service that did not comply to manufacturer's recommendations, and/or the use of non-palisades dental parts - any or all of these factors contributed to the alleged failure.Customer reported failures to be related to two devices -- (b)(4); however, further investigation revealed that only one device was involved in the event.The end user was unable to identify which of the two identified hand pieces was used.Since neither device was serviced by palisades dental and both lacked routine maintenance and included non-palisades dental parts, it is impossible for palisades dental's investigation to conclude which device potentially contributed to the event.

Event Description

It was initially reported that a dentist who was performing a crown and bridge procedure indicated the diamond crown and bridge burs would not stay in the handpiece and came off in the patient's mouth.The dentist was able to retrieve and no patient was harmed.The initial report indicated that the event occurred with two different handpieces and no specifics about the patient was provided.Subsequent investigation revealed that only one handpiece was involved, and confirmed that the patient was not harmed.The dentist and staff could not identify which of the two identified handpieces were involved.

Manufacturer Narrative

On (b)(6) 2017, palisades dental llc was notified by (b)(6) of an event that reportedly involved the use of an impact air 45 handpiece, (b)(4).The initial report stated, "the customer reports that as they were performing a crown and bridge procedure, diamond crown and bridge burs would not stay in the handpiece.As a result, it would come off in the patient's mouth.They were able to retrieve the burs and no patient was harmed.It happened with two different handpieces.The specifics of the patient was not provided.As part of palisades dental's investigation, on 10/10/17 a representative of palisades dental, llc spoke with the dentist who performed the procedure related to the alleged event.The dentist stated that while "working on a tooth doing a crown prep one of the diamond burs shot out, the bur was caught by the suction and found in the filter".It was confirmed by the dentist that, "only one handpiece was involved in the event." neither the dentist nor the staff could identify which of the two handpieces was involved; therefore, they sent both to be checked.The dentist further confirmed that no injury was sustained by the male patient who was approximately (b)(6) of age according to the dentist.The dentist stated that the patient was notified of what happened and was told that the bur was found.The dentist stated that to the best of her knowledge the patient is fine.When asked about the maintenance of the handpieces, the dentist that the handpiece had been sent out for service previously about 1 or 2 months ago because the bur was coming out.The dentist reported that the repair facility told the dental practice that there was no problem found.It was confirmed by the office manager of the dental practice that all handpieces are sent to (b)(6) for service.The dentist did not know what maintenance procedure is used on the handpiece.The dentist stated that she inserted the bur and pulled on it to check it before it as used.On 10/06/17, handpieces (b)(4) were received at palisades dental at the end of the business day.On 10/09/17 palisades dental completed an evaluation on (b)(4) and associated records.It is noted that both handpieces were sold to (b)(6).(b)(4) was sold on (b)(6) 2015 & (b)(4) was sold on (b)(6) 2016 and that neither handpiece had ever been sent to palisades dental for service or evaluation.A review of the manufacturing records for (b)(4) did not find any abnormalities with the batch records or associated documentation.Palisades dental deems no corrective action is needed since palisades dental has determined that the failure is not manufacturer related, rather it is related to lack of routine maintenance, service that did not comply to manufacturer's recommendations, and/or the use of non-palisades dental parts - any or all of these factors contributed to the alleged failure.Customer reported failures to be related to two devices-- (b)(4); however, further investigation revealed that only one device was involved in the event.The end user was unable to identify which of the two identified hand pieces was used.Since neither device was serviced by palisades dental and both lacked routine maintenance and included non-palisades dental parts, it is impossible for palisades dental's investigation to conclude which device potentially contributed to the event.Any information provided by palisades dental, llc in connection with this matter does not constitute an admission, and palisades dental, llc denies that the device or any actions relating to the device caused or contributed to any adverse event.All information provided by palisades dental, llc in connection with this matter is confidential commercial information that may not be disclosed to any third part without permission of palisades dental, llc, except as required by law.Corrected data: (b)(4).In the original 3500a submission, the first sentence of the manufacturer narrative incorrectly reflected serial number #(b)(4).The follow up #1 report has been revised to reflect the correct serial #(b)(4).

Event Description

It was initially reported that a dentist who was performing a crown and bridge procedure indicated the diamond crown and bridge burs would not stay in the handpiece and came off in the patient's mouth.The dentist was able to retrieve and no patient was harmed.The initial report indicated that the event occurred with two different handpieces and no specifics about the patient was provided.Subsequent investigation revealed that only one handpiece was involved, and confirmed that the patient was not harmed.The dentist and staff could not identify which of the two identified handpieces were involved.

• 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: 6972659
• MDR Text Key: 90807467
• Report Number: 3003963943-2017-00003
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 403
• Device Lot Number: 7147,7354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 60 YR