MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5303-90001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aleutian an coronal inserter was fractured and the outer shaft/handle was broken outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Event or Problem Description
It was reported that the tip of an aleutian an coronal inserter was fractured and the outer shaft/handle was broken outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inserter.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, similar complaints were identified.The device was not returned and is unavailable for evaluation.As the device was manufactured in 2015, it is likely that this fracture is a result of regular device usage over the course of 7 years.However, this can not be confirmed.H3 other text : status and location of the device is unknown.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 8.5X28 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: 14691339
• Report Number: 3004774118-2022-00235
• Device Sequence Number: 6777910
• Product Code: LXH
• UDI-Device Identifier: 10888857110458
• UDI-Public: 10888857110458
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/09/2022

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 Model Number: 5303-90001
• Device Catalogue Number: 5303-90001
• Device Lot Number: DGKY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2015
• 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: Male