MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® CLEARVIEW - LEGEND TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	SP12MH25
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results are pending completion of the evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tool experienced a shaft break and displayed signs of overheating.There was no patient impact or injury.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number sp12mh25 from lot number 0213442301.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.Visually, the inner shaft broke which would have resulted in the reported event.The break point corresponds to where the shaft diameter is reduced for the outer tube radius.The distal end of the inner shaft appeared darker than the rest however it is not consistent with heat discoloration, more likely discoloration from wear.Note ¿ the customer indicated the bur showed signs of overheating, and not specifically that it was overheating.The portion that became detached measure 3.938¿ from tip to break.The break itself contained circular patterns which indicates excess torsional loads.The break also contained a flattening of the high points which indicates the break occurred while rotating.The inner shaft diameter 0.03500¿ / +-0.00015¿ measured 0.0350¿ and the reduced shaft diameter 0.0240 / +-0.0005¿ measured 0.0240¿ indicating an in-specification condition and not a cause for excess torsional load.The reported issue of a broken tool was confirmed, however there were no confirmed signs of overheating.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the customer indicates the tool was being run at 60,000 rpm.

• Brand Name: XPS® CLEARVIEW - LEGEND TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 7203947
• Report Number: 1045254-2018-00027
• Device Sequence Number: 16446484
• Product Code: HBE
• UDI-Device Identifier: 00643169308527
• UDI-Public: 00643169308527
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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 Expiration Date: 06/04/2021
• Device Model Number: SP12MH25
• Device Catalogue Number: SP12MH25
• Device Lot Number: 0213442301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1