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

Model Number	ASMC
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was refused to be returned by hospital.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.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 108 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 during a knee case, when the surgeon was reviewing imaging post surgery, that the bearing was identified left in the patient.It was reported that the surgeon did not feel that the bearing needed to be removed.On follow up it was stated that the patient was reported to be doing well post surgery.It was also reported that the hospital refused to return the device at this time.

• Brand Name: LEGEND METAL CUTTER ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX 76137
• MDR Report Key: 7603704
• Report Number: 1625507-2018-00027
• Device Sequence Number: 1695015
• Product Code: HBB
• UDI-Device Identifier: 00613994418814
• UDI-Public: 00613994418814
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: ASMC
• Device Catalogue Number: ASMC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/14/2018
• 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