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

Catalog Number AUTOLUBE-III_LL

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that prior to surgery, it was observed that when the foot pedal was pressed, the foot control device loses power.There were no delays to the scheduled surgical procedure as an identical spare device was available for use.There was no patient involvement.There were no injuries, medical intervention or prolonged hospitalization.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.(b)(4) evaluated the device and observed that the device met all manufacture's specifications.Therefore, the reported condition could not be confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AL-II-FOOT CONTROL
• 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: 4107215
• MDR Text Key: 4713228
• Report Number: 1045834-2014-12886
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK940535
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AUTOLUBE-III_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FOOT PEDAL DEVICE