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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER DRILL BIT BIT, DRILL

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STRYKER ENDOSCOPY STRYKER DRILL BIT BIT, DRILL Back to Search Results
Model Number DRILL, AO. 04.2X340 #1806-420
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2019
Event Type  Injury  
Event Description

Pt in operating room for fixation of left periprosthetic distal femur fracture. When the surgeon was attempting to place the oblique screw, he noted that the pt's knee arthroplasty blocked the trajectory of the drill bit. The drill bit fractured upon attempting to pass the knee arthroplasty. It was removed, and the fragment of the drill bit was able to be retained and removed from the knee. Surgery proceeded without further incident. No harm to pt. Fda safety report id# (b)(4).

 
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Brand NameSTRYKER DRILL BIT
Type of DeviceBIT, DRILL
Manufacturer (Section D)
STRYKER ENDOSCOPY
MDR Report Key8869326
MDR Text Key153786799
Report NumberMW5088862
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 08/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDRILL, AO. 04.2X340 #1806-420
Device LOT NumberK058BAA
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/06/2019 Patient Sequence Number: 1
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