MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48844014
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that during a revision case, the surgeon attempted to implant a 4.0 x 14mm fixed, self- drilling screw.When inserting a new screw into the new plate, the circular ring around the screw fractured.The revision surgery is addressed in a different record.No adverse consequences to the patient is reported due to screw ring fracture.5 minutes delay is reported.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; result: it was reported that during a revision surgery the surgeon attempted to implant a fixed self drilling screw when the circular ring around the screw fractured.The device was returned for evaluation and the reported event was confirmed upon visual inspection.Manufacturing history was reviewed and no anomalies were found.Conclusion: the plausible root cause of the reported event could not be determined conclusively.Some of the potential root causes are the patient could have had a hard bone quality, excessive axial/torsional force could have been applied, the screw may not have been attached securely to the screwdriver, or the guide may not have been used for screw insertion.
Event or Problem Description
It is reported that during a revision case, the surgeon attempted to implant a 4.0 x 14mm fixed, self- drilling screw.When inserting a new screw into the new plate, the circular ring around the screw fractured.The revision surgery is addressed in a different record.No adverse consequences to the patient is reported due to screw ring fracture.5 minutes delay is reported.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X14MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7571481
• Report Number: 0009617544-2018-00128
• Device Sequence Number: 217550
• Product Code: KWQ
• UDI-Device Identifier: 07613252254706
• UDI-Public: 07613252254706
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 08/23/2018

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: No Information
• Device Catalogue Number: 48844014
• Device Lot Number: XSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1