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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L DRILL 5MM MODULAR FLEXIBLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER SPINE-FRANCE ANCHOR L DRILL 5MM MODULAR FLEXIBLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48994150
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2017
Event Type  malfunction  
Event Description
It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.
 
Manufacturer Narrative
The fracture of a drill tip was confirmed via visual inspection.Per analysis, the tip fractured due to unidirectional bending.No material and manufacturing defects were found.The plausible root cause is applying too much cantilever force to the drill.
 
Event Description
It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.
 
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Brand Name
ANCHOR L DRILL 5MM MODULAR FLEXIBLE
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6667985
MDR Text Key78549551
Report Number0009617544-2017-00259
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327274592
UDI-Public(01)07613327274592
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48994150
Device Catalogue Number48994150
Device Lot Number14F926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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