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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7126-120-000
Device Problems Fracture (1260); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2020
Event Type  malfunction  
Event Description
The user facility reported, the housing broke at the weld during a procedure.The broken housing could cause the non-sterile battery to be exposed to the sterile field.No medical intervention, no clinically significant delay and no adverse consequences.
 
Event Description
The user facility reported, the housing broke at the weld during a procedure.The broken housing could cause the non-sterile battery to be exposed to the sterile field.No medical intervention, no clinically significant delay and no adverse consequences.
 
Manufacturer Narrative
Additional information.
 
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Brand Name
SMARTLIFE LARGE ASPETIC HOUSING
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
MDR Report Key9842864
MDR Text Key183757802
Report Number0001811755-2020-00708
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07613327128819
UDI-Public07613327128819
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7126-120-000
Device Catalogue Number7126120000
Device Lot Number19276
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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