MAUDE Adverse Event Report: MSD BARTLETT MFG; BIT, DRILL

Catalog Number 876-943

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient underwent an anterior cervical fusion at c5-c7 to treat cervical spondylotic myelopathy.It was reported that an anterior corpectomy was performed at c6 with iliac bone graft and c5-c7 was fixed with a cervical plate.According to the report, the tip of the drill bit penetrated approximately 1-2 mm into the spinal canal when pilot holes were being drilled.It was reported that no imaging device was used during the procedure.The surgical time was not extended due to the incident.Reportedly, no patient complications were observed post-op.No further information could be obtained.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3741390
• MDR Text Key: 19391171
• Report Number: 1030489-2014-02157
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 876-943
• Device Lot Number: UC08C009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CERVICAL PLATE SYSTEM
• Patient Outcome(s): Other