MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 4X12MM VARIABLE ANGLE SELF TAP.SCREW; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48694012
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; doctor was doing a c3-4 acdf using a 16mm plate with screws.3 screws were successfully inserted, then he was unable to get the 4th screw to fully lock.The screw was removed, the doc was reminded of the angulation parameters of the plate, and a new path was drilled using a 12mm drill and a variable single barrel guide.The doc then tried to insert a screw, but was unable to get it to lock.When he took the screw out, he noticed two metal shards near the screw insertion point.He removed the metal pieces, left the screw out, and completed the case.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assesment; result: two screws were returned and both were inspected under a microscope.The green screw (4x12 lot# nhb) was inspected and it was found that one of the threads was deformed and pieces were starting to fracture off of the thread.No relevant manufacturing issues were found upon device history review.The reflex hybrid risk file includes hazardous situations such as "incorrect alignment- difficulty in screw insertion" and, "too much torsional force - screw damages locking ring - additional time required to remove damaged plate and implant new one" which are relevant to the reported event.Conclusion: the probable root cause of this event is likely due to an incorrect alignment of the screw and too much torsional force applied during the insertion.
Event or Problem Description
It was reported that; doctor was doing a c3-4 acdf using a 16mm plate with screws.Approx 3 screws were successfully inserted, then he was unable to get the 4th screw to fully lock.The screw was removed, the doc was reminded of the angulation parameters of the plate, and a new path was drilled using a 12mm drill and a variable single barrel guide.The doc then tried to insert a screw, but was unable to get it to lock.When he took the screw out, he noticed two metal shards near the screw insertion point.He removed the metal pieces, left the screw out, and completed the case.

• Brand Name: REFLEX-HYBRID 4X12MM VARIABLE ANGLE SELF TAP.SCREW
• 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: 5766249
• Report Number: 0009617544-2016-00265
• Device Sequence Number: 56549
• Product Code: KWQ
• UDI-Device Identifier: 04546540535092
• UDI-Public: (01)04546540535092
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• 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): 06/07/2016

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: 48694012
• Device Lot Number: NHB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1