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

Model Number	87011
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned drivers found that the distal tips of both instruments had fractured and became separated.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.One of the tips was recovered and discarded by the user facility.The second remains implanted within the polyaxial screw, entrapped beneath both the rod and set screw is approximately 4.38mm wide and 2.8mm in length.The section is manufactured from 465ss and is certified to atsm a564 standards.A previous investigation conducted for this type of occurrence determined that this is likely the result of implantation in hard dense bone, which required an increased torsional load that exceeded the design limits of the instrument.
Event or Problem Description
While attempting to implant the 10.5 screws, the tips of both drivers broke and detached from the instruments.One tip was removed from the patient without issue, while the second was retained as it was deemed too difficult to remove.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9564144
• Report Number: 2027467-2019-00063
• Device Sequence Number: 2866312
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565(10)MC163503R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC163503R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• 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
• Patient Age: 51 YR