MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7092-01-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Headache (1880); Laceration(s) (1946)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
During a case, the surgeon and pa were cutting a 5.5mm cocr rod with a tabletop rod cutter.While cutting the rod, a large piece of the head of the rod cutter sheared off and struck the pa in the face above the eye.The sheared off piece of metal flew off, broke through her protective eye wear and caused a gash, bleeding and swelling above the eye.She had to stop what she was doing, collect herself, break scrub and stop the bleeding.It was reported she also had a minor headache.
Additional Manufacturer Narrative
H6: investigation findings: 3243.Investigation conclusion: 61.H10: a review of the device history record did not identify any manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.The device has been in the field since (b)(6) 2021.Only the rod cutter head instrument returned to alphatec for evaluation.The distal tip of the open rod slots is confirmed damaged.There's a significant section of material fractured off from the slot/outer profile of the head piece.There is material wear and smashing on the cutting edge of the 6.35mm slot.The rod cutter is designed to cut rods varying in diameter and curvature.Based on information provided in the complaint and visual inspection, the rod cutter fractured during rod cutting of the 5.5mm cocr rod.This failure mode (fracturing of brittle stainless steel) is commonly seen in high-impact loading.The wear is at the 6.35mm rod slot indicate multiple instances of misuse in cutting undersized rods.Over time the non-perpendicular loading described below from cutting undersized rods can deform and weaken the rod cutter.In this instance a cocr rod (high density material) could not be cut by the device resulting in failure.Labeling review: "warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury." "preoperative management: surgeons should have a complete understanding of the surgical technique, system indications, contraindications, warnings and precautions, safety information, as well as functions and limitations of the implants and instruments.Careful preoperative planning should include construct strategy, pre-assembly of component parts (if required), and verification of required inventory for the case." intraoperative management: "if it is mandatory to cut the rods to a more specific length, rod cutting should be done at a distance from the operative range, and such that a non-sharp edge remains on the rod." inspection: 'inspect instruments for any other damage, wear, and/or corrosion.".

• Brand Name: INVICTUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15636418
• Report Number: 2027467-2022-00076
• Device Sequence Number: 19523455
• Product Code: LXH
• UDI-Device Identifier: 00190376367194
• UDI-Public: (01)00190376367194(10)CH31984
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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
• Device Model Number: 7092-01-01
• Device Catalogue Number: 7092-01-01
• Device Lot Number: CH31984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female