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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA GMBH STRYKER GAMMA 3 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA GMBH STRYKER GAMMA 3 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Insufficient Information (4580)
Event Date 02/07/2022
Event Type  Injury  
Event Description
Stryker gamma 3 trochanteric nail was used on an inter trochanteric fracture. Nail cut through the femoral head which had to be fixed with a different device. Fda safety report id # (b)(4).
 
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Brand NameSTRYKER GAMMA 3
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA GMBH
MDR Report Key13506504
MDR Text Key285474144
Report NumberMW5107356
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
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