MAUDE Adverse Event Report: K2M, INC. MESA RAIL / ROD PULLER; MESA RAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	801-90143
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a mesa rail/rod puller became deformed during a surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Device was discarded.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.It was reported that a mesa rail/rod puller became deformed during a surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.Per additional correspondence, the event occurred while removing the screws / rods.The device was not used at a difficult angle, the bone quality of the patient was reported to be hard and excessive force was applied.Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include application of excessive force, hard bone quality of patient, normal wear due to excessive use or age of device, etc.
Event or Problem Description
A company representative reported that a mesa rail/rod puller became deformed during a surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: MESA RAIL / ROD PULLER; MESA RAIL
• 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: 13895942
• Report Number: 3004774118-2022-00113
• Device Sequence Number: 4596148
• Product Code: LXH
• UDI-Device Identifier: 10888857143654
• UDI-Public: 10888857143654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/23/2022

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: 801-90143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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