MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number MA-D20

Device Problem Difficult To Position (1467)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was reported that during service and repair pre-testing, it was observed that the attachment device was heating in excess.The event was not related to surgery.There was no patient involvement reported.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.

Manufacturer Narrative

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.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which found that there was excess heat due to excessive corrosion on the internal components which was indicative of not following emersion / sterilization procedures.The assignable root cause was determined to be due to component damage caused by misuse, abuse and/ or user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MINIMAL ACCESS ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• 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: 4564973
• MDR Text Key: 5554869
• Report Number: 1045834-2015-10482
• 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: Health Professional,Company Representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA-D20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1