MAUDE Adverse Event Report: ALPHATEC SPINE INC 5.5MM TAP (STAINLESS STEEL); HWX

Model Number 87007-055

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 07/28/2014

Event Type  malfunction  

Event Description

The arsenal tap broke in the patients s1 pedicle.The detached part was removed from pedicle and it appears that no loose fragments remain in the patient.

Manufacturer Narrative

Mdr being submitted as a result of a retrospective complaint review.No evaluation possible.The user facility would not release the instrument due to their internal investigation.Although the instrument in question was not returned for evaluation, 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.

• Brand Name: 5.5MM 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: 4903874
• MDR Text Key: 6070762
• Report Number: 2027467-2015-00123
• 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
• 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: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 87007-055
• Device Catalogue Number: 87007-055
• Device Lot Number: 7099603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• 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): Hospitalization; Other
• Patient Age: 36 YR