MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 2MM FLUTED BALL, EXT; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number S-2B

Device Problem Naturally Worn (2988)

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

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

This is event 1 of 2 of the same event.It was reported from (b)(6) that during a cochlear implant surgical procedure, it was observed that the cutter device flutes on the ball were flat and not sharp.According to the reporter, the event had previously occurred on different occasions while using the cutter devise but no exact information was available.There were no delays to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional narrative: (b)(4).Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not duplicated or confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that there was black discoloration on the tip which indicates insufficient irrigation during the procedure contrary to dfu (directions for use).A dimensional assessment was performed which determined that all measurable features met specifications.A functional test was performed and this burr exhibited a normal cut rate for this burr design.This burr design employs the use of a primary on the edge of the cutting flutes which is intended to make them less aggressive than a standard fluted burr.They are used in proximity of the facial nerve during ent procedures where great care must be taken not to damage the nerve.The assignable root cause was determined to be due to component damage caused by use error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Correction: the lot number was inadvertently documented as serial number in the initial report.It has been updated as (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2MM FLUTED BALL, EXT
• 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: 6417148
• MDR Text Key: 70375363
• Report Number: 1045834-2017-10688
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-2B
• Device Lot Number: J473111541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2017; 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLUTED BALL DEVICE