MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 30; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a typical anterior cervical discectomy and fusion surgery, the cervical 2 level plate's top left side locking mechanism popped off and fell into the surgery area.All broken fragments were removed using a pair of bayonetted pickups.The surgeon removed plate and replace with a new plate.A surgical delay of 30 min was reported.No adverse consequences to the patient were reported.The surgery was completed successfully.
Event or Problem Description
During a typical anterior cervical discectomy and fusion surgery, the cervical 2 level plate's top left side locking mechanism popped off and fell into the surgery area.All broken fragments were removed using a pair of bayonetted pickups.The surgeon removed plate and replace with a new plate.A surgical delay of 30 min was reported.No adverse consequences to the patient were reported.The surgery was completed successfully.
Additional Manufacturer Narrative
Methods: the returned device was confirmed visually to have the spring bar unattached from the plate.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Results: the customer reported event was confirmed via visual inspection.Conclusion: the root cause of the spring bar fracture is undetermined.Potential root causes include: user tilts guide off axis affecting screw path, over-angulation of screwdriver which leads to unintended cantilever force, guide not properly attached to plate, and/or guide/awl limits visibility.The ifu state, "do not apply cantilever loads while the drill is engaged in the bone.Do not squeeze trigger until after drill guide is fully inserted into screw hole.The trigger must be fully depressed prior to and during drilling to ensure that the fixed angle trajectory and the desired depth are achieved.The trigger must be released prior to removing the fixed drill guide from the plate to avoid potential damage to the plate or spring bar.Use of either the fixed drill guide or the fixed punch awl sleeve is required if fixed screws are desired.If fixed angle screws are not inserted at the correct trajectory, damage to the plate or bone screw could occur.Do not cantilever the guide during removal from plate as it can damage locking mechanism.".

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8265189
• Report Number: 0009617544-2019-00008
• Device Sequence Number: 16548375
• Product Code: KWQ
• UDI-Device Identifier: 07613252152194
• UDI-Public: 07613252152194
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 48811230
• Device Lot Number: 186519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 111