MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48844018
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded by hospital.
Event or Problem Description
A company representative reported that the heads of two aviator fixed self-drilling screws fractured during surgery.The procedure was completed successfully with a thirty-minute surgical delay and no adverse consequence to the patient.This report captures the second of two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.The reported issue of intra-operative screw fracture whereby the tabs fractured off two (2) screws was confirmed by photographs sent in by the stryker rep.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.
Event or Problem Description
A company representative reported that the heads of two aviator fixed self-drilling screws fractured during surgery.The procedure was completed successfully with a thirty-minute surgical delay and no adverse consequence to the patient.This report captures the second of two screws.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X18MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14141198
• Report Number: 0009617544-2022-00050
• Device Sequence Number: 19906798
• Product Code: KWQ
• UDI-Device Identifier: 07613252254720
• UDI-Public: 07613252254720
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 48844018
• Device Catalogue Number: 48844018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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