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

Catalog Number	48844014
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon was using a plate.One of the screws was bottoming out and would not go below the plate.Tried a rescue screw and it did better.One minute delay.
Additional Manufacturer Narrative
Lot# pax.Method: visual analysis, device history review, complaint history review, risk assessment.Result: too much compressive torque during insertion of screw by the screwdriver results in breakage of screw tab.There was no breakage of the screw however some deformations on the threads were identified upon visual inspection.Conclusion: an excess compressive force and the deformation in the screw may have likely caused the reported event of screw jamming.
Event or Problem Description
It was reported that; the surgeon was using a plate.One of the screws was bottoming out and would not go below the plate.Tried a rescue screw and it did better.One minute delay.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X14MM
• 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: 5732072
• Report Number: 0009617544-2016-00238
• Device Sequence Number: 622818
• Product Code: KWQ
• UDI-Device Identifier: 07613252254706
• UDI-Public: (01)07613252254706
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 05/25/2016

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: 48844014
• Device Lot Number: PAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1