MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 4MM FLUTED BALL; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number QD8-4B

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  Injury  

Event Description

This is report 3 of 4 of the same event.It was reported that during an unspecified foot surgery, it was observed that the motor device, attachment device and cutter device ¿were making funny noises and metal shavings were falling into the surgical site¿ when in use together.The reporter stated that the motor device was switched with a spare motor device.The same attachment device and cutter device were utilized with the spare motor device.According to the report, it was again observed that the devices were making funny noises and metal shavings were falling into the surgical site¿.As a result, there was a five minute delay to the surgical procedure.There was patient involvement.There were no reports of injuries or prolonged hospitalization.It was unknown to the reporter if radiology imaging was utilized.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not duplicated or confirmed.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4MM FLUTED BALL
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• 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: 3771077
• MDR Text Key: 20714858
• Report Number: 1045834-2014-11838
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD8-4B
• Device Lot Number: F023060230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICE; MOTOR DEVICE; MOTOR DEVICE
• Patient Outcome(s): Required Intervention