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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a medical procedure the rasp broke off in the attachment.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a medical procedure the rasp broke off in the attachment.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.

• 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: 11146915
• Report Number: 0001811755-2021-00055
• Device Sequence Number: 11636476
• 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): 03/31/2021

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?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5407120472 SN (B)(6).; 5407120472 SN1925510163