MAUDE Adverse Event Report: K2M, INC. SCREW, SELF STARTING; SIZE Ø5.0X48 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	4501-15048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip of a cayman self starting screw broke off intra-operatively during final tightening.The screw was removed, there was no reported surgical delay.
Additional Manufacturer Narrative
Device was discarded.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device associated with this record was not returned.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was reported that the head of a cayman self starting screw broke off intra-operatively during final tightening.The screw was removed, there was no reported surgical delay.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.Potential causes include: torque limiting handle not used during final tightening, excess force applied to torque the screw, etc.
Event or Problem Description
It was reported that the tulip of a cayman self starting screw broke off intra-operatively during final tightening.The screw was removed, there was no reported surgical delay.

• Brand Name: SCREW, SELF STARTING; SIZE Ø5.0X48 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 13654554
• Report Number: 3004774118-2022-00076
• Device Sequence Number: 2481134
• Product Code: KWQ
• UDI-Device Identifier: 10888857093270
• UDI-Public: 10888857093270
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131533
• 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): 06/08/2022

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 Model Number: 4501-15048
• Device Catalogue Number: 4501-15048
• Device Lot Number: NUYO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown