MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1883519HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis found out that the reported event ¿broken and faulty out of the packet¿ insinuates that the device was defective before use in the package however the biological contaminants inside the device and outside indicate use.The middle assembly would index freely however the inner assembly with resistance which is typical of spiral wrap damage from excess speed or improper direction.The inner hub was 0.07¿ from its typical position in relation to the rotating hub which is consistent with a stretched spiral wrap.There was some wear to the cutting teeth however it is not likely a causal effect of the reported event.The blade loaded into a handpiece however due to the resistance of the inner assembly, and pressure from the stretched spiral wrap, it would not function.A review of the global complaint data showed no other similar complaints for this lot number.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates irregular torsional loads from improper speed or direction resulted in the observed damage and lack of function.The labeled maximum recommended speed for this device is 3,000 rpm in oscillate mode / direction.The user¿s guide warns ¿powered blades should be operated in the oscillate mode only.Operating in the forward mode may cause damage to the blade.¿ if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that a device was broken and faulty out of the packet during the procedure.There was no patient involvement.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9841244
• Report Number: 3004209178-2020-05514
• Device Sequence Number: 19551068
• Product Code: EQJ
• UDI-Device Identifier: 00885074080659
• UDI-Public: 00885074080659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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 Expiration Date: 03/18/2023
• Device Model Number: 1883519HR
• Device Catalogue Number: 1883519HR
• Device Lot Number: HG3941C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1