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

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.

• Brand Name: SELF CONSTRAINED AWL (STAINLESS STEEL)
• Type of Device: HWJ
• 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 Key: 7039007
• MDR Text Key: 93138928
• Report Number: 2027467-2017-00083
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• 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 Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 61730
• Device Catalogue Number: 61730
• Device Lot Number: 5873701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other