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

Model Number	AUTOLUBE-III
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported from (b)(6) that the autolube device had an oil leak.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was noted that the event occurred in (b)(6) 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was not confirmed.It was further determined that the device failed to pass the gauge assessment due to particles inside and the foot pad had discoloration.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: AUTOLUBE-III
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7379444
• Report Number: 1045834-2018-50628
• Device Sequence Number: 19141390
• Product Code: GEY
• UDI-Device Identifier: 00845384000396
• UDI-Public: (01)00845384000396(11)140219
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K970530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2018

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 Model Number: AUTOLUBE-III
• Device Catalogue Number: AUTOLUBE-III
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/23/2018; 07/26/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/02/2018; 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1