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

Catalog Number	5101-90160
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two everest xt mi rod reducer tower tips broke off intra-operatively.The procedure was completed successfully without surgical delay.This report represents the first of the two everest xt mi rod reducer tower tips.
Additional Manufacturer Narrative
The returned device was visually and functionally inspected.Upon functional inspection, the device was connected to a test rod and reduced down to check for connection stability.The device was not able to perform as intended, as main body jamming was observed during analysis.The device was not fractured as reported.This event is not reportable as no death or serious deterioration in state of health of a patient, user, or other person has occurred or is likely to occur.
Event or Problem Description
It was reported that two everest xt mi rod reducer tower tips broke off intra-operatively.The procedure was completed successfully without surgical delay.This report represents the first of the two everest xt mi rod reducer tower tips.Upon investigation, this device was not found to be fractured- the device experienced jamming issues.

• Brand Name: MI ROD REDUCER; XT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11276409
• Report Number: 3004774118-2021-00031
• Device Sequence Number: 14327783
• Product Code: LXH
• UDI-Device Identifier: 10888857279391
• UDI-Public: 10888857279391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/28/2021

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: 5101-90160
• Device Lot Number: GGFF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1