MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE HELIOCOIDAL RASP; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	5820080021
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device evaluated by manufacturer? awaiting device return.
Event or Problem Description
It was reported during a spine surgery procedure two helicoidal rasps broke.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a ten minute delay and the procedure was completed successfully.This report is for the second helicoidal rasp that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: device not returned.
Event or Problem Description
It was reported during a spine surgery procedure two heliocoidal rasps broke.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a ten minute delay and the procedure was completed successfully.This report is for the second heliocoidal rasp that broke.

• Brand Name: ELITE HELIOCOIDAL RASP
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11473922
• Report Number: 0001811755-2021-00730
• Device Sequence Number: 16963093
• Product Code: HWE
• UDI-Device Identifier: 07613153022374
• UDI-Public: 07613153022374
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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 Model Number: 5820080021
• Device Catalogue Number: 5820080021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1