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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE HELIOCOIDAL RASP; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE HELIOCOIDAL RASP; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 5820080021
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
 
Event Description
It was reported that during a medical procedure, the metal cutting rasp broke.No further information was provided.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
 
Event Description
It was reported that during a medical procedure, the metal cutting rasp broke.No further information was provided.
 
Event Description
It was reported that during a medical procedure, the metal cutting rasp broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
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Brand Name
ELITE HELIOCOIDAL RASP
Type of Device
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 Key11900691
MDR Text Key253152034
Report Number3015967359-2021-00993
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07613153022374
UDI-Public07613153022374
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5820080021
Device Catalogue Number5820080021
Device Lot Number21044017
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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