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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.7MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.7MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 5820103017
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Event Description
It was reported that the drill bit broke during a surgical procedure.It was also reported that the broken piece was retrieved from the patient.It was also reported that there were no adverse consequences as a result of this event.No further information was provided.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported that the drill bit broke during a surgical procedure.It was also reported that the broken piece was retrieved from the patient.It was also reported that there were no adverse consequences as a result of this event.No further information was provided.
 
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Brand Name
1.7MM WIRE PASS DRILL BIT
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11393583
MDR Text Key234048256
Report Number0001811755-2021-00717
Device Sequence Number1
Product Code HBE
UDI-Device Identifier04546540362438
UDI-Public04546540362438
Combination Product (y/n)N
PMA/PMN Number
K143320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/14/2021
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
Device Operator Health Professional
Device Expiration Date08/01/2023
Device Model Number5820103017
Device Catalogue Number5820103017
Device Lot Number20237017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Initial Date Manufacturer Received 02/04/2021
Initial Date FDA Received03/01/2021
Supplement Dates Manufacturer Received04/14/2021
Supplement Dates FDA Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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