MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF TAPPING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48814014
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported that, whilst implanting a cervical plate, two of the self-tapping screws, ¿would not pass the locking mechanism.¿ all other screws implanted in the adjacent levels were placed without issue.The physician, ¿felt it would jeopardize the integrity of the construct to remove and replace all the screws and place a new plate,¿ and so opted to complete surgery without the two aforementioned screws.There was no adverse consequence to the patient.The product labelling indicates that, ¿the insertion of the implants must be carried out using instruments designed and provided for this purpose and in accordance with the specific implantation instructions for each implant.¿.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Product and complaint history could not be performed as a valid lot code was not provided and could not be obtained.It was reported that a screw jammed intra-operatively.The event resulted a 1-2 minute surgical delay.A root cause could not be determined.Possible root causes are: screw inserted at an angle; screw hole drilled at an angle; screw not driven below spring bar.
Event or Problem Description
Physician reported that, whilst implanting a cervical plate, two of the self-tapping screws, ¿would not pass the locking mechanism.¿ all other screws implanted in the adjacent levels were placed without issue.The physician, ¿felt it would jeopardize the integrity of the construct to remove and replace all the screws and place a new plate,¿ and so opted to complete surgery without the two aforementioned screws.There was no adverse consequence to the patient.The product labelling indicates that, ¿the insertion of the implants must be carried out using instruments designed and provided for this purpose and in accordance with the specific implantation instructions for each implant.¿.

• Brand Name: AVIATOR VARIABLE SELF TAPPING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8563266
• Report Number: 0009617544-2019-00061
• Device Sequence Number: 16741018
• Product Code: KWQ
• UDI-Device Identifier: 07613252152507
• UDI-Public: 07613252152507
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 48814014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR