MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 1.55MM X 10MM FLUTED TWIST DRL; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number S-1510TD

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

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

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that during an unspecified surgical procedure the "tip" of the cutter device "broke off".The report indicated that "when the surgeon tried to make five or more holes in bone flap for tenting, the tip of the twist drill in question broke off".The report indicated that the "broken tip of twist drill was removed without any problem".It was further clarified that since tenting was performed out of operating field, the piece of the device did not fall into the patient's skull.There were no reports of injuries, medical intervention or prolonged hospitalization.There was no delay to the planned surgical procedure.It was unknown if a spare device was available for use.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).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.

Manufacturer Narrative

The actual device was returned for evaluation.  reliability engineering evaluated the device.  a visual inspection of this device was performed under 10x magnification which confirmed the reported condition.  the assignable root cause was determined to be exposure to excessive lateral force during use. the device met all dimensional specifications.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.55MM X 10MM FLUTED TWIST DRL
• 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: 3677062
• MDR Text Key: 4302086
• Report Number: 1045834-2014-11646
• 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: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-1510TD
• Device Lot Number: G273080945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR