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	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a mesa deformity rail/rod puller was observed to be 'slightly bent' intra-operatively.
Event or Problem Description
It was reported that the tip of a mesa deformity rail/rod puller was observed to be 'slightly bent' intra-operatively.
Additional Manufacturer Narrative
A visual inspection was performed.Wear was found on the tip of the device and one of the inner shaft prongs was completely bent inward.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number and lot number was performed.No adverse trends were observed and no lot commonality exists.It was reported that when unlocking the rail, the nurse gave the surgeon the mesa1 unlocker instead of the rail unlocker.As a result, the inner collet of the screw broke off on both sides.The surgeon tried to remove the damaged screw using the rail/ rod puller, but the tip of the rail/ rod puller was slightly bent, so he could not remove it from the rod.Therefore, the damaged screw was pulled out while it was still on the rod.Based on the deformation and wear found on the puller, it is likely that excessive compressive force was applied downward on the device, causing the tip to deform, and the puller to not properly grab the rail.It cannot be determined if this damage occurred in this surgery or a previous one.Wear resulting from the devices age (5 years) may also have contributed to the event.

• 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: 13453405
• Report Number: 3004774118-2022-00047
• Device Sequence Number: 5893466
• Product Code: LXH
• UDI-Device Identifier: 10888857171220
• UDI-Public: 10888857171220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: ELET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/19/2016
• 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