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

Catalog Number	48694014
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a drill was used on power with variable drill guide, 30mm plate 4.0x14mm variable self-tapping screw.Inserted the screws with stab and grab driver.Upon final tightening with gold driver, two screws went completely through the plate.Upon inspection after removal it was identified that the rim just below the head of the screw was stripped off of the screw.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment results: the returned devices were confirmed visually to have deformed collars on the head.Manufacturing records for this product were reviewed and no anomalies were found.Conclusion: it appears that the surgical technique was followed so the root cause is not determined and multifactorial.
Event or Problem Description
It was reported that a drill was used on power with variable drill guide, 30mm plate 4.0x14mm variable self-tapping screw.Inserted the screws with stab and grab driver.Upon final tightening with gold driver, two screws went completely through the plate.Upon inspection after removal it was identified that the rim just below the head of the screw was stripped off of the screw.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF TAP.SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5458131
• Report Number: 0009617544-2016-00077
• Device Sequence Number: 357025
• Product Code: KWQ
• UDI-Device Identifier: 04546540534804
• UDI-Public: 04546540534804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/03/2016

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: NBB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1