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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7208000000
Device Problems Vibration (1674); Electrical Power Problem (2925); Device Handling Problem (3265)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/27/2019
Event Type  Injury  
Event Description
It was reported by the user facility during a hip prosthesis that the motor suddenly stopped while cutting.It was further reported that the patient's bone broke during the procedure.The procedure was then completed successfully after the bone was repaired.No additional adverse consequences were associated with this event.
 
Manufacturer Narrative
Upon evaluation by a manufacturer technician it was found during device evaluation that the sag saw head components were worn.A worn drive link on blade mount base failure or worn bearings in the sag head assembly can affect device functionality and cause or contribute to the handpiece vibrating while cutting.A vibrating handpiece that also has functionality issues, such as a loss of function or intermittent function, could cause an event in which there could be a sudden motion causing the reported event; however, this was not confirmed.
 
Event Description
It was reported by the user facility during a hip prosthesis that the motor suddenly stopped while cutting.It was further reported that the patient's bone broke during the procedure.The procedure was then completed successfully after the bone was repaired.No additional adverse consequences were associated with this event.
 
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Brand Name
SYSTEM 7 SAGITTAL SAW
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8466329
MDR Text Key140361668
Report Number0001811755-2019-01012
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07613252251033
UDI-Public07613252251033
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7208000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2019
Is the Reporter a Health Professional? No
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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