MAUDE Adverse Event Report: ALPHATEC SPINE INC STRAIGHT BONE PROBE (STAINLESS STEEL); HXB

Model Number	73746
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records revealed no manufacturing, processing or design related irregularities.The illico bone probe was found to be properly manufactured and released in accordance with the device master record.Visual inspection found that the distal tip had fractured and separated from the device at the 30mm depth indicator.The bone probe is designed to locate the proper pathway and length of the screw which is to be implanted.When used as intended the instrument would not come in contact with the amount of force required to deform and/or break the tip in this manner.
Event or Problem Description
An international customer ((b)(6)) reported the complaint as "handle (knurled barrel) is broken, plastic ring dissolves, because of a material defect".The information also indicated that no patient was involved when the irregularity was identified.

• Brand Name: STRAIGHT BONE PROBE (STAINLESS STEEL)
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5795862
• Report Number: 2027467-2016-00054
• Device Sequence Number: 594080
• Product Code: HXB
• UDI-Device Identifier: 00844856044203
• UDI-Public: 00844856044203
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2015

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: Other
• Device Model Number: 73746
• Device Catalogue Number: 73746
• Device Lot Number: 6635302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2016
• Initial Report FDA Received Date: 07/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other