MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS AUTOLUBE-III WITH MA7; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	AUTOLUBE-III-MA7
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588); Device Operates Differently Than Expected (2913); Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).The 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.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was observed that the foot control device had an oil leak, oil loss, torn hose and defective lock.It was further determined that the device failed pre-test for muffler lock assembly, detent assessment, drip rate, foot switch and oil leak it was noted in the service order that the hose was torn.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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.

• Brand Name: AUTOLUBE-III WITH MA7
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 5829421
• Report Number: 1045834-2016-12320
• Device Sequence Number: 700949
• Product Code: GEY
• Combination Product (Y/N): N
• PMA/510(K) Number: K970530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial
• Report Date (Section B): 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AUTOLUBE-III-MA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2016
• Initial Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1