Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM SWANSON PILOT POINT BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM SWANSON PILOT POINT BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1608002135
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.Device discarded.
 
Event or Problem Description
It was reported that the cutting end of the bur broke during a surgical procedure.It was also reported that the broken piece was retrieved from the patient.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4.0MM SWANSON PILOT POINT BUR
Common Device Name
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12175117
Report Number3015967359-2021-01417
Device Sequence Number16517319
Product Code GFF
UDI-Device Identifier04546540030542
UDI-Public04546540030542
Combination Product (Y/N)N
Initial Reporter StateWY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/15/2021
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 Number1608002135
Device Catalogue Number1608002135
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/22/2021
Initial Report FDA Received Date07/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-