MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48558524
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon had placed the screw in bone and had difficult time disengaging a screwdriver from screw.Upon turning screwdriver handle to left to disengage, the tulip broke off the screw with tulip still attached to screwdriver but screw still remaining in bone.Surgeon had difficult time engaging poly driver with bone screw, so vice grip was utilized to grip screw head and manually back out of bone.The broken screw was replaced with the same size screw.Surgical delay was 5 mins.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records for this product were reviewed and no anomalies were found.The tulip was confirmed separated based on visual examination.The root cause is multifactorial.
Event or Problem Description
It was reported that the surgeon had placed the screw in bone and had difficult time disengaging a screwdriver from screw.Upon turning screwdriver handle to left to disengage, the tulip broke off the screw with tulip still attached to screwdriver but screw still remaining in bone.Surgeon had difficult time engaging poly driver with bone screw, so vice grip was utilized to grip screw head and manually back out of bone.The broken screw was replaced with the same size screw.Surgical delay was 5 mins.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6269849
• Report Number: 0009617544-2017-00020
• Device Sequence Number: 11074632
• Product Code: KWP
• UDI-Device Identifier: 04546540596437
• UDI-Public: (01)04546540596437
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• 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): 03/24/2017

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: 48558524
• Device Lot Number: 164578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1