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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC SELF CONSTRAINED AWL (STAINLESS STEEL) HWJ

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ALPHATEC SPINE INC SELF CONSTRAINED AWL (STAINLESS STEEL) HWJ Back to Search Results
Model Number 61730
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 10/23/2017
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the returned device revealed a fragment of the distal tip had broken and detached from the instrument. The remainder of the pointed edges are slightly bent/deformed and no longer sharp. The manipulation appears to be consistent with that of possibly impacting/striking with excessive force at the proximal end of the instrument. The self constrained awl is designed to create a pilot hole through cortical bone by pushing down on the handle of the instrument.

 
Event Description

An international customer ((b)(6)) reported that the tip of the awl is broken.

 
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Brand NameSELF CONSTRAINED AWL (STAINLESS STEEL)
Type of DeviceHWJ
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad CA 92008
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, CA 92008
7604946842
MDR Report Key7039007
MDR Text Key93138928
Report Number2027467-2017-00083
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 10/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number61730
Device Catalogue Number61730
Device LOT Number5873701
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/16/2017 Patient Sequence Number: 1
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