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 05/24/2022

Event Type  malfunction  

Event Description

It was reported that an aleutian an coronal inserter and outer shaft/handle were broken at the base intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the outer shaft/handle.

Event Description

It was reported that an aleutian an coronal inserter and outer shaft/handle were broken at the base intra-operatively.Upon further inspection of the outer shaft/handle, it was found that there were no identiifed issues with this device.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the outer shaft/handle.

Manufacturer Narrative

Upon further inspection of the outer shaft/handle, it was found that there were no identiifed issues with this device.Report 3004774118-2022-00246 has been filed for the inserter inner shaft which fractured at the tip.

• 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: 14777590
• MDR Text Key: 296078288
• Report Number: 3004774118-2022-00247
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2022
• 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