MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN BURRS & DRILLS; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number UNK-BURRS-&-DRILLS

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 2 of 2 for the same event.It was reported that during an unspecified surgical procedure, it was observed that an unknown drill bit device became stuck inside the motor device.It was reported that there was no delay in the procedure due to the event as unspecified spare devices were available for use to complete the procedure successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.It was documented in the initial medwatch report that an unknown burr device had become stuck in the motor device.However, upon receipt and inspection of the motor device it was determined that there was no cutter device stuck in the motor device.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.

• Brand Name: UNKNOWN BURRS & DRILLS
• Type of Device: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7402356
• MDR Text Key: 104836830
• Report Number: 1045834-2018-50702
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BURRS-&-DRILLS
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1