MAUDE Adverse Event Report: K2M, INC. LORDOTIC AN INSERTER; SIZE 24 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5203-90100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threaded component of the inner shafts broke off of two aleutian an lordotic inserters intra-operatively.There were no adverse consequences to the patient.This report captures the second inserter.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number and lot number was performed and no adverse trends were observed.It was reported that the threaded part of the inner shafts broke when disengaged from the holder intra-operatively.The event was confirmed via correspondence with the representative who also reported that the device was not used at a difficult angle, no excessive force was used, and bone quality was unknown.As the device was not returned, a definite cause cannot be determined.Possible causes include excessive force applied, cantilever force applied, inadequate disc prep leading to more force applied during insertion, and/or the cage not being fully inserted onto the inserter.The device was over five years old at the time of the event, so wear from its extended use may have contributed to the event.H3 other text: device was discarded.
Event or Problem Description
It was reported that the threaded component of the inner shafts broke off of two aleutian an lordotic inserters intra-operatively.There were no adverse consequences to the patient.This report captures the second inserter.

• Brand Name: LORDOTIC AN INSERTER; SIZE 24 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13502080
• Report Number: 3004774118-2022-00055
• Device Sequence Number: 14431928
• Product Code: LXH
• UDI-Device Identifier: 10888857108141
• UDI-Public: 10888857108141
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5203-90100
• Device Lot Number: EKRU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• 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: Unknown