MAUDE Adverse Event Report: K2M, INC. INSERTER, OUTER SHAFT/HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 5303-90004

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Event 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 handle.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog number, similar complaints were identified.The device was not returned and is unavailable for evaluation.Photos provided show an intact outer shaft, therefore, it is likely that there is no problem with the outer shaft, and the reported fracture is only affecting the inserter.

Event 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 handle.

• Brand Name: INSERTER, OUTER SHAFT/HANDLE
• Type of Device: 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: 14691402
• MDR Text Key: 295316232
• Report Number: 3004774118-2022-00236
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10888857110489
• UDI-Public: 10888857110489
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5303-90004
• Device Catalogue Number: 5303-90004
• Device Lot Number: KYRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male