MAUDE Adverse Event Report: K2M, INC. SCREW DRIVER W/ THREAD; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	8801-90034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of 2 ozark screw drivers fractured off during intra-operative screw insertion.The surgeon was unable to remove the broken tip as it is now stuck in the screw head.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.This report will capture the second of the two screw drivers.
Event or Problem Description
It was reported that the tips of 2 ozark screw drivers fractured off during intra-operative screw insertion.The surgeon was unable to remove the broken tip as it is now stuck in the screw head.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.This report will capture the second of the two screw drivers.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed tip to be fractured.Additionally, rotational deformation was observed just proximal to the fracture around entire hexalobe.A review of complaint history associated with this lot number was performed and no adverse trends were observed.It was reported that the patient had hard bone and a greater-than-normal force had to be applied to insert the screws.The degree of deformation observed on the device suggests that excessive torque was applied.A second device associated with this event (captured in mrn 3004774118-2022-00009) also exhibited rotational deformation which further substantiates that the most likely root cause is excessive torque due to the patient¿s hard bone.

• Brand Name: SCREW DRIVER W/ THREAD; SIZE 10
• 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: 13197205
• Report Number: 3004774118-2022-00010
• Device Sequence Number: 17222384
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/14/2022

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: 8801-90034
• Device Lot Number: JVKP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male
• Patient Weight: 155 KG