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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.
 
Manufacturer Narrative
Additional information: d9.
 
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.
 
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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 Key9842861
MDR Text Key183757018
Report Number0001811755-2020-00707
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 Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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