MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS TOOL LEGEND 10 CM 3MM DIAM CRS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	10BA30DC
Medical Device Problem Codes	Material Separation (1562); Dull, Blunt (2407)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool returned had part of the diamond coating detached.The missing portion of the coating was not returned.Discoloration was present in the neck area of the tool stem and longitudinal scratches were present on stem and tool head.The likely cause was identified as the findings were consistent with the tool reprocessed with a wire brush or similar object that damaged the substrate and caused the diamond media and substrate loss.Reduction in the substrate resulted in the reduction of adhesion power to secure the diamond media and reduction of tool head diameter.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.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 doctor noticed that the diameter of the tool tip ball of 10ba30dc become smaller for about 1 mm after cutting the lumbar for about 20 to 30 mins.It was also reported that the diamond and metal from the tool which were considered to have entered into the patient's body were aspirated to the extent that they could be aspirated with both saline and bone fragments.It was also stated that although it was impossible to remove all the things which had entered into the patient's body, no abnormalities was observed when the patient was being monitored after the procedure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TOOL LEGEND 10 CM 3MM DIAM CRS
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; ft. worth TX 76137
• MDR Report Key: 7741147
• Report Number: 1625507-2018-00040
• Device Sequence Number: 2542298
• Product Code: HBE
• UDI-Device Identifier: 00643169757561
• UDI-Public: 00643169757561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/02/2018

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 Expiration Date: 02/10/2023
• Device Model Number: 10BA30DC
• Device Catalogue Number: 10BA30DC
• Device Lot Number: H5409852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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