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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STEMCOR SYSTEMS, INC. MARROWMINER SYSTEM FLEXSHAFT BONE MARROW ASPIRATION DEVICE

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STEMCOR SYSTEMS, INC. MARROWMINER SYSTEM FLEXSHAFT BONE MARROW ASPIRATION DEVICE Back to Search Results
Lot Number STEM042309-01
Event Date 09/21/2009
Event Type  Malfunction  
Event Description

The flexshaft tip malfunctioned and separated from the instrument. The tip could not be retrieved from the iliac crest.

 
Manufacturer Narrative

(b)(4). The failed units all showed evidence of over-swaging. Investigation showed contract manufacturer had reprocessed some units using a secondary swaging process when tip did not meet the od specification. Secondary swaging process was shown to reduce tensile strength. No units from this lot will be placed into distribution. This problem occurred with the first unit shipped from this lot. No units remain in the field. Contract manufacturer's work instructions will be modified to eliminate swaging reword. Additionally, tensile testing will be added as a 100% in-process test to avoid this error in the future.

 
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Brand NameMARROWMINER SYSTEM FLEXSHAFT
Type of DeviceBONE MARROW ASPIRATION DEVICE
Manufacturer (Section D)
STEMCOR SYSTEMS, INC.
menlo park CA
Manufacturer (Section G)
STELLARTECH
1346 bordeaux dr.
sunnyvale CA 94089
Manufacturer Contact
801 hermosa way
menlo park , CA 94025
6503216884
MDR Report Key2671310
Report Number2952366-2009-00001
Device Sequence Number1
Product CodeKNW
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 10/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2010
Device LOT NumberSTEM042309-01
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/21/2009
Is The Reporter A Health Professional? No
Date Manufacturer Received09/21/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/23/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/30/2009 Patient Sequence Number: 1
Treatment
NONE. BONE MARROW ASPIRATION PROCEDURE WAS
CONTINUED WITH A STANDARD ASPIRATION NEEDLE.
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