MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF TAPPING SCREW 4.35X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48834514
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted in patient.
Event or Problem Description
It was reported that part of an aviator fixed self tapping screw sheared off during surgery.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device remains implanted.A review of the device history records could not be performed as a valid lot number was not provided and could not be obtained.A complaint history review for similar events for the subject catalog number was performed, and no adverse trends were observed.Per surgical technique guide: caution: use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent damage to implants, difficulty locking the blocker, or locking mechanism malfunction.If self-tapping screws are selected, use a single barrel drill guide or all-in-one drill guide to guide the appropriate drill bit.If self-drilling screws are used, use either the punch awl with a sleeve or a drill bit and drill guide to center and direct the pathway of the screw.Operative notes were not provided.Patient details are unknown.Device was not returned so an evaluation could not be performed.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: patient hard bone quality, improper screw hole preparation- drill/ drill guide not used, rescue driver and draw rod incorrectly aligned with screw, application of excessive force, etc.
Event or Problem Description
It was reported that part of an aviator fixed self tapping screw sheared off during surgery.Surgery was successfully completed with a 15 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: AVIATOR FIXED SELF TAPPING SCREW 4.35X14MM
• 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-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12909952
• Report Number: 0009617544-2021-00224
• Device Sequence Number: 5120676
• Product Code: KWQ
• UDI-Device Identifier: 07613252254645
• UDI-Public: 07613252254645
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142237
• 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): 03/07/2022

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: 48834514
• Device Catalogue Number: 48834514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/08/2022
• 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