MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM; HWX

Model Number 87107-055

Device Problem Break (1069)

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

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the suspect device revealed no manufacturing or processing related irregularities.The instrument was found to be properly manufactured and released in accordance with design specifications.Visual inspection of the returned arsenal tap revealed the instrument fractured and separated at the 60mm depth indicator.The fractured ends appear to be crisp and clean and suggest the break occurred in snapping motion rather than a rotation direction that would be expected with the instruments intended use.Under magnification, the edges of both corresponding halves display an angulated fracture pattern indicative of excessive lateral bending.

Event Description

Surgeon was tapping into bone and it snapped right above the threads.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Type of Device: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 9444000
• MDR Text Key: 191679518
• Report Number: 2027467-2019-00057
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 00840967126838
• UDI-Public: (01)00840967126838(10)7673704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87107-055
• Device Catalogue Number: 87107-055
• Device Lot Number: 7673704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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