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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 Problem Disassembly (1168)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 12/22/2016
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility that the device ball bearing fell off the device and into the patient.The ball bearing was retrieved and the patient was given an x-ray to ensure that no additional material was in the patient.The x-ray showed that no additional material was within the patient.The procedure was completed successfully without a clinically significant delay.
 
Manufacturer Narrative
Supplemental submitted to document device evaluation results.
 
Event Description
It was reported that during a surgical procedure at the user facility that the device ball bearing fell off the device and into the patient.The ball bearing was retrieved and the patient was given an x-ray to ensure that no additional material was in the patient.The x-ray showed that no additional material was within the patient.The procedure was completed successfully without a clinically significant delay.
 
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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 Key6263074
MDR Text Key65211423
Report Number0001811755-2017-00099
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
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 Manufacturer01/13/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2014
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) Other;
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