MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF TAPPING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48814016
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threading of an aviator self tapping screw fractured intra-operatively.A metal shard from the screw was located and removed from the surgical site before procedure close.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that the threading of an aviator self tapping screw fractured intra-operatively.A metal shard from the screw was located and removed from the surgical site before procedure close.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
A small metal fragment was returned.It cannot be determined conclusively if this fragment is from an aviator screw.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained from the material fragment returned.Complaint history records for the device catalog were reviewed, no similar complaints were identified.Based on the additional information, the screw holes were prepared with 14mm aviator drill bit however the all-in-one-guide was not used.The surgery was performed at difficult angle and the drill may have been over angulated.The aviator surgical technique indicates: 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.As there is not enough information to determine if the fragment came from an aviator screw, the cause of the event cannot be determined.However since the all-in-one drill guide was not used and the implantation angle was difficult, it is possible the screw got damaged during insertion.The hard stop when the drill guide is fully inserted (snap-in feature), fixed guide limiting angulation, the tip of the drill guide that mimics the screw hole and thus limiting the bending motion are features that could have prevented damage to the screw.

• Brand Name: AVIATOR VARIABLE SELF TAPPING SCREW 4X16MM
• 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: 12737644
• Report Number: 0009617544-2021-00215
• Device Sequence Number: 14646219
• Product Code: KWQ
• UDI-Device Identifier: 07613252152514
• UDI-Public: 07613252152514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/08/2022

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: 48814016
• Device Catalogue Number: 48814016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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