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

Model Number	22SPT09
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument have not been returned.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
Surgeon was pushing the gear shift into the pedicle and the tip of the instrument broke off.The surgeon easily removed the broken tip and the patient was not harmed.
Additional Manufacturer Narrative
An evaluation of the returned lenke straight 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 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.

• 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: 8116693
• Report Number: 2027467-2018-00084
• Device Sequence Number: 1656922
• Product Code: HXB
• UDI-Device Identifier: 00840967190105
• UDI-Public: (01)00840967190105(10)6690009
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: Health Professional
• Device Model Number: 22SPT09
• Device Catalogue Number: 22SPT09
• Device Lot Number: 6690009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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