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

Model Number	5820080021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that two metal cutting rasps broke during the same procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the two rasps which were reported to have broken.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that two metal cutting rasps broke during the same procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the two rasps which were reported to have broken.

• Brand Name: ELITE HELIOCOIDAL RASP
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11424175
• Report Number: 0001811755-2021-00725
• Device Sequence Number: 11866380
• Product Code: HWE
• UDI-Device Identifier: 07613153022374
• UDI-Public: 07613153022374
• 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
• Initial Reporter Occupation: Other
• 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 Expiration Date: 06/01/2025
• Device Model Number: 5820080021
• Device Catalogue Number: 5820080021
• Device Lot Number: 20175017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/05/2021
• 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