MAUDE Adverse Event Report: ALPHATEC SPINE, INC. LOCKING POLYAXIAL SCREWDRIVER (STAINLESS STEEL); HXX

Model Number	87011
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the returned polyaxial screwdriver found that the distal tip had fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The detached portion which 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
The tip of the screw driver broke off inside of the screw.The patient outcome was good and no complications.

• Brand Name: LOCKING POLYAXIAL SCREWDRIVER (STAINLESS STEEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7464203
• Report Number: 2027467-2018-00022
• Device Sequence Number: 13489635
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: Physician
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: 7617501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: 62 YR