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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5820103015
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported that during a cranial procedure, the bur overheated, leaving a black trace on the bone flap.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if the device is available.
 
Event Description
It was reported that during a cranial procedure, the bur overheated, leaving a black trace on the bone flap.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.The bur was returned for evaluation and noted to be broken.
 
Manufacturer Narrative
H2: device was returned and was broken, this was evaluated by product engineering.H6: the quality investigation is complete.
 
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Brand Name
1.5MM 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
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
colette chung
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key18756635
MDR Text Key335943755
Report Number3015967359-2024-00411
Device Sequence Number1
Product Code HBE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K143320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/22/2024
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 Catalogue Number5820103015
Device Lot Number23198017
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5407120450: S/N: (B)(6).
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