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

Model Number	22SPT09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The second pedicle probe returned is product part number 22spt10, lot # 6803902 manufactured 12/31/2012.An evaluation of both returned lenke probes found the instruments had broken approximately 35 mm from the distal tip.The 35 mm location is the transition point where the 6.35 mm diameter shaft tapers down to the pointed tip.The distal pointed 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 distal tip of two pedicle probes were found broken upon return to spd.

• Brand Name: PEDICLE PROBE, LENKE STRAIGHT (STAINLESS STEEL)
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6567316
• Report Number: 2027467-2017-00038
• Device Sequence Number: 18988672
• Product Code: HXB
• UDI-Device Identifier: 00840967190105
• UDI-Public: 00840967190105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/20/2017

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: 22SPT09
• Device Catalogue Number: 22SPT09
• Device Lot Number: 6401901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/15/2017
• 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