MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 2MM DBALL,EX,S; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number S-2D-G1

Device Problems Difficult To Position (1467); Vibration (1674)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported that during an unspecified ear, nose, and throat (ent) surgical procedure, it was observed that the handpiece device experienced wobble when used with a 2mm burr device at a decreased operational speed of 40,000 rotations per minute (rpm).It was further observed that there was not as much wobble when operational speed was increased to 80,000 rpm.It was reported that there was no delay in the procedure due to the event.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Upon subsequent follow-up with the customer, additional information was received.The reporter stated that the burr device did not fit into the drill, the drill turned briefly when power was cycled, and there was still a slight kick when the pedal was depressed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 2MM DBALL,EX,S
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 6656235
• MDR Text Key: 78031588
• Report Number: 1045834-2017-11360
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-2D-G1
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2017
• 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: N
• Patient Sequence Number: 1