MAUDE Adverse Event Report: K2M, INC. MI OFFSET ROD REDUCER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90012
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 everest mi offset rod reducers showed signs of material wear and were not retaining the screw heads outside of the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two reducers.
Event or Problem Description
It was reported that 2 everest mi offset rod reducers showed signs of material wear and were not retaining the screw heads outside of the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the first of the two reducers.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed for this lot as a valid lot code was not provided and could not be obtained.It was reported that the device was used hundreds of times over the course of 3-4 years and complex and excessive force were likely used.As the device was not returned, a definite cause cannot be determined, but based on the reported usage, wear from the device's extended use is the likely cause.

• Brand Name: MI OFFSET ROD REDUCER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11807253
• Report Number: 3004774118-2021-00141
• Device Sequence Number: 3647009
• Product Code: LXH
• UDI-Device Identifier: 10888857104006
• UDI-Public: 10888857104006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/08/2021

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: 5101-90012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1