MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS LEGEND ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number	AA07
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was not returned for evaluation.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.The preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device has been in use for approximately 125 months with no record of factory service during this period.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the attachment suddenly overheats during spine surgery and the patient was burned in the operated area.It was reported that the patient is alive with injury and that no additional treatment was needed post - surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On further follow up, it was confirmed that the patient was burned on the spine area.The patient is now healing.
Additional Manufacturer Narrative
Report confirmed.The device was tested and the temperature was measured to be 129 degree fahrenheit.The likely cause of failure could not be determined.It was also noted that there is no evidence that any other failures during analysis were found that may have contributed to this event.It was also noted that the rear nut was stuck in the attachment and could not be removed for further analysis.(b)(4) was added based on the initial report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LEGEND ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX
• MDR Report Key: 7760027
• Report Number: 1625507-2018-00043
• Device Sequence Number: 1560258
• Product Code: HBB
• UDI-Device Identifier: 00721902481888
• UDI-Public: 00721902481888
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA07
• Device Catalogue Number: AA07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/20/2018; 12/24/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/18/2018; 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR