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

Model Number	AUTOLUBE-III
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
Event or Problem Description
It was reported that during service and repair pre-testing, it was discovered that the hose of the autolube device was ruptured and cracked.It was further reported that the gauge was damaged, the base plate was bent, and the device was deformed/bent.It was further determined that the device failed pretest for visual assessment, gauge condition and high pressure assessment.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: AUTOLUBE-III
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10875691
• Report Number: 1045834-2020-01935
• Device Sequence Number: 11749685
• Product Code: GEY
• UDI-Device Identifier: 00845384000396
• UDI-Public: 00845384000396
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1