MAUDE Adverse Event Report: K2M, INC. POWER PULLER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	801-90097
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa power puller bent intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed, the tip of the puller is deformed and bent inwards.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and catalog number, no adverse trends were identified.The device was manufactured in 2013, making it 9 years old.Based on the age of the device, the most likely cause is wear from the device's extended use.Excessive force and misalignment of the device with the rod could also cause the deformation found on the device.
Event or Problem Description
It was reported that a mesa power puller bent intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: POWER 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: 13506434
• Report Number: 3004774118-2022-00056
• Device Sequence Number: 5324719
• Product Code: LXH
• UDI-Device Identifier: 10888857143425
• UDI-Public: 10888857143425
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 801-90097
• Device Lot Number: BXBY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2013
• 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