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

Catalog Number	5101-90160
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside the or an everest xt rod reducer came apart at the tip.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.
Event or Problem Description
It was reported that outside the or an everest xt rod reducer came apart at the tip.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.
Additional Manufacturer Narrative
The returned everest mi xt rod reducer was visually inspected.The instrument was confirmed to be damaged.The distal end of the instrument had fractured at the weld point, between the bottom outer shaft and the top outer sleeve.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It is believed the instrument was not used at a difficult angle, and no excessive forces were used on the device.The complainant was unaware of how long they have been in possession of the instrument, and could not estimate its usage.Fracture of the weld site can occur due to consistent use of the instrument over time leading to fatigue, off-axis loading, or abnormal forces.The root cause for the reported failure cannot be conclusively determined.

• 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
• 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: 12858064
• Report Number: 3004774118-2021-00370
• Device Sequence Number: 4245373
• Product Code: LXH
• UDI-Device Identifier: 10888857279391
• UDI-Public: 10888857279391
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/09/2022

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 Catalogue Number: 5101-90160
• Device Lot Number: MBFY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown