MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PERFORATOR DRIVER W/HUDSON END; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER

Catalog Number CSR60

Device Problem Positioning Problem (3009)

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

Event Type  malfunction  

Event Description

It was reported that during an unspecified neuro surgery, it was observed that the compact speed reducer device was not rotating.There were no delays to the surgical procedure as an identical spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device gearbox was worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PERFORATOR DRIVER W/HUDSON END
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER
• 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: 4635048
• MDR Text Key: 5618399
• Report Number: 1045834-2015-10668
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1