MAUDE Adverse Event Report: ALPHATEC SPINE INC ILLICO MIS POSTERIOR FIXATION SYSTEM; HWX

Model Number	73715
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tip of the tap was broken and remains entrapped within the patient's bone.Although the polyaxial screws are self-tapping, taps may be used during pedicle preparation to facilitate screw insertion.The cannulation of the tap (through hole) is slid over the guidewire after the site has been dilated to the appropriate diameter.The bone is then tapped to the desired depth.Taps come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter.An evaluation 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 tip, which remains positioned within the patient, was manufactured from 465ss (stainless steel) and is certified to astm a564 specifications.It appears that this occurrence 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
Customer reported the patient had very hard bone.The tip of the tap broke while the surgeon was creating a hole into the pedicle.The tip of the tap remained lodged in the bone.

• Brand Name: ILLICO MIS POSTERIOR FIXATION SYSTEM
• Common Device Name: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11634314
• Report Number: 2027467-2021-00014
• Device Sequence Number: 19707197
• Product Code: HWX
• UDI-Device Identifier: 00844856044005
• UDI-Public: (01)00844856044005
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 73715
• Device Catalogue Number: 73715
• Device Lot Number: 5665802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/08/2021
• 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