MAUDE Adverse Event Report: ALPHATEC SPINE INC 4.5 MM TAP (STAINLESS STEEL); HWX

Model Number 87007-045

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned instrument found it had fractured and separated at the 60mm depth grove indicator.Both sections of the device were returned.The patient did not retain a foreign body.A previous investigation for this type of event found the design of flute depth and geometry, as well as epoxy groove geometry was inappropriate for this application.Contributing factors include surgical technique and misuse, patient bone quality, improper measurement technique of the flutes.An update of the dimensions and material of the arsenal taps and has been implemented to reduce this type of event.Additionally, further investigation on improving inspection methods in collaboration with vendor has identified potential for significant improvement in inspection method.Current accepted inspection process is in place.

Event Description

During pedicle preparation, an arsenal 4.5mm tap bent and then broke.The surgeon was able to retrieve the distal end of the tap from the patient's pedicle with the aid of a needle driver.

• Brand Name: 4.5 MM TAP (STAINLESS STEEL)
• Type of Device: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 5078777
• MDR Text Key: 26193703
• Report Number: 2027467-2015-00181
• Device Sequence Number: 1
• Product Code: HWX
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 87007-045
• Device Catalogue Number: 87007-045
• Device Lot Number: 7404901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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