MAUDE Adverse Event Report: SYNEA; HIGHSPEED HANDPIECE

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

We, w and h, as the manufacturer of the device have not received sufficient information and have not received the device for evaluation.The us distributor a-dec inc.Reported following narrative: "(b)(6) staff reported to a-dec that device did not malfunction.This is evidenced by the fact the device was returned to handpiece rotation.To help alleviate similar events, a-dec sent the (b)(6) staff a chuck strength tester at no charge." we currently try to obtain further information from the user to be able to investigate this case further and we will file a supplemental report.

• Brand Name: SYNEA
• Type of Device: HIGHSPEED HANDPIECE
• Manufacturer Contact: ignaz-glaser-strasse 53; buermoos 5111 ; 2746236397
• MDR Report Key: 4477562
• MDR Text Key: 5401002
• Report Number: 9681479-2015-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1