MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF TAP.SCREW; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48694014
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon insertion of the screw with stab and grab driver, the locking clip of the screw sheared off and the screw was able to advance completely through the plate and into the vertebral body.Single barrel variable drill guide, along with the 14mm drill bit on power was used to prepare the screw hole prior to screw insertion.The screw was able to be removed.
Additional Manufacturer Narrative
Method: risk assessment; results: manufacturing records for this product were not reviewed because the hospital misplaced the screw and it was not returned.Conclusion: the stryker rep reported that the screw hole was prepared as recommended by the stg so the root cause cannot be determined without the parts.
Event or Problem Description
It was reported that upon insertion of the screw with stab and grab driver, the locking clip of the screw sheared off and the screw was able to advance completely through the plate and into the vertebral body.Single barrel variable drill guide, along with the 14mm drill bit on power was used to prepare the screw hole prior to screw insertion.The screw was able to be removed.

• Brand Name: REFLEX-HYBRID 4X14MM 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: 5606349
• Report Number: 0009617544-2016-00159
• Device Sequence Number: 45194
• Product Code: KWQ
• UDI-Device Identifier: 04546540535108
• UDI-Public: (01)04546540535108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K040261
• 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): 03/28/2016

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: 48694014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1