MAUDE Adverse Event Report: GYRUS ACMI, INC. MASTOID ROUND CUTTING BURR

Model Number 70327041

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

Hospital has reported the following incident.Started with scrub nurse opened 2 new burrs, x1 5mm and x1 3mm, kept packets for re-ordering, placed 5mm into viper mastoid drill, setup on patient ready to use, who completed no equipment concerns, surgery started.Halfway through the surgery where the drill was now required.The surgeon asked for drill and the nurse informed setup on patient ready for use, consultant surgeon held in hand as insert in front of microscope he noticed the burr was dirty with what looked like bone dust and traces of blood.The surgeon informed nurse of his discovery and asked the nurse to remove the dirty burr and passed the burr out (b)(6).(b)(6) placed dirty burr back into packet.(b)(6) opened a new 5mm burr and handed over to the nurse.The nurse then checked the burr, placed into the viper mastoid drill, handed over to the surgeon, surgery continued as per usual.

Manufacturer Narrative

The customer's complaint of bone dust on the burr head was unconfirmed.The returned burr did have contaminates on the burr head but they cannot be categorized as bone dust until further material analysis is performed.The (b)(4) is a pull and pack item which means it is received from the supplier, stocked and then pulled and packaged in a rotary seal pouch before being sent off for sterilization and then stocked for commercial usage.After an visual inspection performed at ops sequence 10 before packaging.There are no additional manufacturing processes that this device is subjected to after it is received from the supplier.

Event Description

Hospital has reported the following incident.Started with scrub nurse opened 2 new burrs, x1 5mm and x1 3mm, kept packets for re-ordering, placed 5mm into viper mastoid drill, setup on patient ready to use, who completed no equipment concerns, surgery started.Halfway through the surgery where the drill was now required.The surgeon asked for drill and the nurse informed setup on patient ready for use, consultant surgeon held in hand as insert in front of microscope he noticed the burr was dirty with what looked like bone dust and traces of blood.The surgeon informed nurse of his discovery and asked the nurse to remove the dirty burr and passed the burr out (b)(6).(b)(6) placed dirty burr back into packet.(b)(6) opened a new 5mm burr and handed over to the nurse.The nurse then checked the burr, placed into the viper mastoid drill, handed over to the surgeon, surgery continued as per usual.

• Brand Name: MASTOID ROUND CUTTING BURR
• Type of Device: BURR
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: angela caputo ; 136 turnpike rd; southborough, MA 01772 ; 5088042667
• MDR Report Key: 5439127
• MDR Text Key: 38287903
• Report Number: 1037007-2016-00001
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 70327041
• Device Lot Number: JC944938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: No
• Device Age: 7 MO
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention