MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BEARING SLEEVE, 15CM CURVED; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number MA-15C_AO

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned for service, however did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the device reflected heat with a reading of (b)(4) degrees fahrenheit which was greater than the manufacturers' specification ((b)(4)).Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to worn out bearings from normal 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.

Event Description

It was reported that during service and repair pre-testing, it was discovered that the attachment device was overheating.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BEARING SLEEVE, 15CM CURVED
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - 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: 5694958
• MDR Text Key: 47668356
• Report Number: 1045834-2016-11824
• 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: company representative,health
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA-15C_AO
• Device Lot Number: E413056066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1