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

Catalog Number AUTOLUBE-III

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the foot control device was leaking air from a hole in the hose.There were no delays to the planned surgical procedure.A spare device was used to complete the procedure successfully.There were no reports of 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.Reliability engineering evaluated the device and observed that the device had a cut in the hose, there was debris in the chamber and the knob was in the wrong position.During repair it was observed that the pin came out preventing the knob from returning to the correct position.Therefore, the reported condition was confirmed.The assignable root cause for the hole in the hose is consistent with mishandling of the device by allowing the hose to come in contact with a sharp object which punctured the hose or exerting extreme force on the hose during cleaning or use.The assignable root cause for the pin coming out is consistent with mishandling by dropping or hitting the device against something causing the pin to come loose and falling out.The assignable root cause for the debris in the chamber is consistent with normal wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 6449015
• MDR Text Key: 71331076
• Report Number: 1045834-2017-10783
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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?: Yes
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2006
• 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