MAUDE Adverse Event Report: ALPHATEC SPINE INC PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL); HXB

Model Number 22SPT10

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information provided by the sales rep revealed the patient had really hard dense bone.A mallet was used to advance the probe into the patients pedicle when it broke.The detached tip of the probe was removed from the patient without issue.An evaluation of the returned lenke curved probe found the instrument had broken approximately 35mm from the distal tip.The 35mm location is the transition point where the 6.35mm diameter shaft tapers down to the pointed curved tip.The distal pointed curved tip contains the smallest diameter on the instrument, and is subject to the most stress during use.Bone probes are 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 fracture and/or deform the tip in this manner.

Event Description

The tip of curved probe fractured and broke during use.The event caused no patient harm.

• Brand Name: PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL)
• Type of Device: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 5624718
• MDR Text Key: 45280896
• Report Number: 2027467-2016-00025
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00840967190112
• UDI-Public: 00840967190112
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 22SPT10
• Device Catalogue Number: 22SPT10
• Device Lot Number: 6505607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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