MAUDE Adverse Event Report: MILESTONE SCIENTIFIC COMPUDENT/WAND PLUS

Model Number WA-2050-301

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/04/2015

Event Type  Injury  

Event Description

A compudent instrument was used in conjunction with a wand handpiece to perform a dental anesthetic injection.The user installed the wand handpiece to the instrument and performed a successful inferior alveolar block injection.After delivering the first cartridge, the user removed the needle from the mandibular tissue, replaced the spent cartridge with a new one, then gave the second injection.Upon removing the handpiece from pt's mouth, the needle separated from the handpiece and lodged in the pt's buccalmucosa.The pt was taken to an oral surgeon, who discussed two alternative treatment plans with the pt.The surgeon could surgically remove the needle or leave the needle in place and observe the condition, with the option of removal at a later time if the needle created any problem.The pt opted to leave the needle in place for the time being and continue to monitor the situation.The pt was not experiencing any discomfort or other issue due to the embedded needle.

Manufacturer Narrative

The handpiece was not returned to milestone for eval.Therefore, it is not possible to determine the actual failure mode.Info from the dentist's interview, a review of the product labeling and field return data was used in the analysis of this event.In this case the dentist used a handpiece with a 30 gauge 1 inch long needle attached.The product labeling recommends a handpiece with a 27 gauge 1 1/4 inch long needle attached for this type of injection.Without the actual handpiece, it cannot be determined if the use of the shorter, thinner needle contributed to this adverse event.However, the use of a shorter needle would make recovery of the needle more difficult.Note: the needle is not manufactured by milestone scientific.It is a purchased item.

• Brand Name: COMPUDENT/WAND PLUS
• Manufacturer (Section D): MILESTONE SCIENTIFIC; 220 s. orange ave; livingston NJ 07039
• Manufacturer Contact: stephen solomon ; 220 south orange ave.; livingston, NJ 07039 ; 9735352717
• MDR Report Key: 4890761
• MDR Text Key: 15900536
• Report Number: 3004082685-2015-00001
• Device Sequence Number: 1
• Product Code: EJI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA-2050-301
• Device Lot Number: 140403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other