MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 5MM CARBIDE FLUTED BALL, 10 FLUTES; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number QD8-5B-C-10F

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 01/13/2014

Event Type  Injury  

Event Description

It was reported that during an anterior cervical discectomy and fusion surgical procedure the cutting burr device ¿broke¿ when in use with an attachment and motor device.According to the report, a part of the cutting burr device fell into the patient and was retrieved with forceps.The reporter stated that there were no fragments, missing pieces, or jagged edges on the device.It was further reported that there was a ¿clean break¿.As a result, there was a one minute delay to the surgical procedure.A spare attachment and cutting burr device were available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The patient¿s outcome post-surgical procedure was normal.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

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device.A visual and dimensional assessment was performed which confirmed that the laser marking was not applied in accordance with specifications.The energy from the laser embrittles the carbide material, making it easier to fracture.Per the specification, the laser mark is not to intersect with the distal bearing in the attachment as this is where sideload on the shaft is the greatest.This device was marked one-half inch outside of the specification which allows the marked section of the shaft to align with the distal tip bearing of the attachment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to operator error in the manufacturing process.This issue has been escalated to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5MM CARBIDE FLUTED BALL, 10 FLUTES
• 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: 3622973
• MDR Text Key: 4156795
• Report Number: 1045834-2014-11406
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD8-5B-C-10F
• Device Lot Number: G403084770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE; ATTACHMENT DEVICE
• Patient Outcome(s): Required Intervention