MAUDE Adverse Event Report: K2M, INC. SPRING LOADED AWL; SIZE 20 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4508-90075
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
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 the cayman united awl broke intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Event or Problem Description
It was reported that the cayman united awl broke intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed and it was confirmed that the distal tip is worn and the dowel pin that secures the inner shaft to the outer shaft is fractured.Device history records were reviewed for the corresponding lot and no relevant issues were identified.The device is almost 3 years old.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that the device broke intra-operatively when prepping the screw.Follow up revealed that the device was used at a normal angle.The patient had an osteophyte and hard bone that made it had to cut through which bent the awl.The most likely cause of the reported event is fracture due to difficult patient's anatomy and tip wear due to device age.

• Brand Name: SPRING LOADED AWL; SIZE 20 MM
• 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: 12929099
• Report Number: 3004774118-2021-00378
• Device Sequence Number: 5696525
• Product Code: LXH
• UDI-Device Identifier: 10888857095526
• UDI-Public: 10888857095526
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/15/2022

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: 4508-90075
• Device Lot Number: JCPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2019
• 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