MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS AUTOLUBE-III; MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL

Catalog Number AUTOLUBE-III

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported in the service order from (b)(6) that the foot control device had a torn hose and was leaking oil.The event was not related to surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.The exact date of this 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 the reported condition of an oil leak was confirmed.An assessment was performed on the device which found oil loss, the elbow was without the pin, and the hose was worn.It was also noted that the device failed pre-repair diagnostic tests for drip rate assessment.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: AUTOLUBE-III
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL
• 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: 6069129
• MDR Text Key: 59020782
• Report Number: 1045834-2016-13099
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AUTOLUBE-III
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2007
• 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