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

Catalog Number AUTOLUBE-III-DISS

Device Problems Device Stops Intermittently (1599); Pressure Problem (3012)

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

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the device had been tampered with as it had the incorrect hose.It was determined that this was due to misuse.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 a surgical procedure of the spine it was observed that the foot control device was working intermittently.The reporter stated that the foot pedal was surging and having fluctuating air pressure.It was reported that the drills, air supply, and hoses used in the procedure had been verified to be correct.It was reported that there was no delay due to the event as the same device was used to successfully to complete the procedure.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown; however, the reporter stated that the event occurred approximately two months ago in 2015.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The initial medwatch report noted in section d10 that the device was not returned for evaluation.However, the device was returned and the evaluation was completed at the time of submission of the initial report.Please note that the correct return date has been updated in section d10 of this supplemental medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: AUTOLUBE-III WITH DISS ADAPTER
• 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: 5191762
• MDR Text Key: 30343251
• Report Number: 1045834-2015-12353
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AUTOLUBE-III-DISS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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