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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
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STRYKER SPINE-FRANCE DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. Back to Search Results
Model Number 48080230
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 08/18/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a case the snake arm would not latch onto tubes.Three snake arms were tried and all failed.
 
Event or Problem Description
It was reported that during a case the snake arm would not latch onto tubes.3 snake arms were tried and all failed.
 
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Brand Name
DECOMPRESSION TUBE SNAKE ARM
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key6858971
Report Number0009617544-2017-00355
Device Sequence Number16474998
Product Code LXH
UDI-Device Identifier07613327263909
UDI-Public(01)07613327263909
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/30/2017
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 Model Number48080230
Device Catalogue Number48080230
Device Lot Number14E523
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2017
Initial Date Received by Manufacturer 08/18/2017
Supplement Date Received by Manufacturer08/18/2017
Initial Report FDA Received Date09/12/2017
Supplement Report FDA Received Date11/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Weight136
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