MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR FIXED SELF DRILLING SCREW 4X16MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48844016
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, implanting a plate, the surgeon used an awl to prepare the screw hole.When inserting the fixed self drilling screw the surgeon had to reposition the screw.When redirecting the screw the trajectory (tabs on the outside of the female hex) one of the tabs broke off.The broken piece was retrieved and the same sized screw used to complete the surgery.No adverse consequences reported.
Additional Manufacturer Narrative
Method: visual inspection; risk assessment; results: manufacturing files were not reviewed because the lot number was obliterated by the damage on the screw.The stryker rep reported that no drill guides were used.One self drilling screw was confirmed to have fractured head conclusion: the root cause is not using the drill guides as specified.
Event or Problem Description
It was reported that during surgery, implanting a plate, the surgeon used an awl to prepare the screw hole.When inserting the fixed self drilling screw the surgeon had to reposition the screw.When redirecting the screw the trajectory (tabs on the outside of the female hex) one of the tabs broke off.The broken piece was retrieved and the same sized screw used to complete the surgery.No adverse consequences reported.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X16MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6034771
• Report Number: 0009617544-2016-00417
• Device Sequence Number: 13662867
• Product Code: KWQ
• UDI-Device Identifier: 07613252254713
• UDI-Public: (01)07613252254713
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2016

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: 48844016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1