MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SINAL FIXATION SYSTEM; HWX

Model Number	17109-045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Initial report stated the tip of the tap was bent.Upon receipt of the tap, it was identified the tip had broke off.Review of the device history records did not identify any manufacturing or processing related irregularities.The invictus tap was found to be properly manufactured and released in accordance with design specifications.An evaluation found that the distal tip was fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The instrument was manufactured from 465ss (stainless steel) and is certified to astm a564 specifications.It appears that the tip fracture was likely the result of use in hard dense bone, which required an increased torsional load that exceeded the design limits of the instrument.
Event or Problem Description
Cannulated tap bent during a case.

• Brand Name: INVICTUS SINAL FIXATION SYSTEM
• Common Device Name: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11657616
• Report Number: 2027467-2021-00018
• Device Sequence Number: 19916194
• Product Code: HWX
• UDI-Device Identifier: 00190376192055
• UDI-Public: (01)00190376192055(10)8622001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 17109-045
• Device Catalogue Number: 17109-045
• Device Lot Number: 8622001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1