MAUDE Adverse Event Report: ALPHATEC SPINE INC TI CANNULATED POLYAXIAL SCREW 7.5MM X 40MM (TI-6AL-4V ELI); NKB, MNH, MNI

Model Number 73875-40

Device Problem Failure to Advance (2524)

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

Event Date 04/30/2013

Event Type  malfunction  

Event Description

An international customer (b)(6) reported that stock (illico cannulated screw) at a hospital would not allow a guide wire to pass through the illico screwdriver when mated with the screw.

Manufacturer Narrative

Mdr being submitted as a result of a retrospective complaint review.An investigation found that a guide wire will not pass through the illico screwdriver when mated to illico cannulated screw (p/n 73875-40).The cannulation of the screw was not properly aligned to the cannulation of the instrument causing an interference fit of the two mates.The defect was isolated to a single bone screw p/n 62675-40-01 lot 645500, a component used in the finished assembly of the illico screw (73875-40).The position of the cannulation hole was found outside the location tolerance of 0.010 at the proximal end.The defective implants were removed from the field via voluntary removal# 2027467-7/1/2013-003-r (ref.Z-2086-2013).Removal /termination actions were completed october 9, 2014.

• Brand Name: TI CANNULATED POLYAXIAL SCREW 7.5MM X 40MM (TI-6AL-4V ELI)
• Type of Device: NKB, MNH, MNI
• 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: 4863059
• MDR Text Key: 5812765
• Report Number: 2027467-2015-00095
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 73875-40
• Device Catalogue Number: 73875-40
• Device Lot Number: 649654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2086-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other