MAUDE Adverse Event Report: AESCULAP , INC. AESCULAP; DRILL BIT

Model Number SC430R

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

The surgeon was closing on a c5-c7 anterior cervical discectomy and fusion (acdf).At the end of the procedure, the surgeon noticed metal pieces in the incision along with a spiral spring like piece of metal.Scrub person thought it looked like metal was from drill bit.Drill bit was handed off of field.Circulator wiped her gloved hand over the spirals of the drill bit and metal shavings came off the drill bit.

• Brand Name: AESCULAP
• Type of Device: DRILL BIT
• Manufacturer (Section D): AESCULAP , INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 3975420
• MDR Text Key: 15178888
• Report Number: 3975420
• Device Sequence Number: 1
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SC430R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2014
• Patient Sequence Number: 1
• Patient Age: 52 YR