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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA II DRIVER FOR XIA3 SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
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STRYKER SPINE-US XIA II DRIVER FOR XIA3 SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. Back to Search Results
Catalog Number IS2285XLP
Medical Device Problem Codes Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/10/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the screwdriver end broke during case.
 
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk.No relevant manufacturing issues were identified as all units met specifications.The device was confirmed to have a tip fracture.The most likely root cause is wear due to the device's extended use.
 
Event or Problem Description
It was reported that the screwdriver end broke during case.
 
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Brand Name
XIA II DRIVER FOR XIA3 SCREW
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key6305683
Report Number3004024955-2017-00008
Device Sequence Number16251593
Product Code LXH
UDI-Device Identifier07613327142006
UDI-Public(01)07613327142006
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue NumberIS2285XLP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 01/11/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date02/06/2017
Supplement Report FDA Received Date05/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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