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

Model Number	22SPT10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5624718
• Report Number: 2027467-2016-00025
• Device Sequence Number: 16147297
• Product Code: HXB
• UDI-Device Identifier: 00840967190112
• UDI-Public: 00840967190112
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2016

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 05/03/2016
• 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