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

Catalog Number	6201-90050
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a mesa rail/rod puller appeared "pinched" during pre-operative device inspection.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
The device was inspected and the inner shaft distal tips were bent inward.Superficial wear was found on the outer shaft tips and on the handles.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history was reviewed and two similar complaints for the reported catalogue number were identified.It is unknown under what condition the device was used in when the deformation occurred.There is presence of wear on the device.It is likely the deformation occurred from excessive force applied during a previous surgery, improper assembly/disassembly of the instrument, and/or rough handling.
Event or Problem Description
A company representative reported that a mesa rail/rod puller appeared "pinched" during pre-operative device inspection.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: MESA RAIL / ROD PULLER
• 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: 13455991
• Report Number: 3004774118-2022-00048
• Device Sequence Number: 12023655
• Product Code: LXH
• UDI-Device Identifier: 10888857171220
• UDI-Public: 10888857171220
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/11/2022

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: 6201-90050
• Device Lot Number: NHWV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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