MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND 9.5X100 POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	4826195100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw became bound in a patients bone and broke in the process of trying to remove it.In addition, a screwdriver also broke in the process of trying to remove the screw.
Additional Manufacturer Narrative
Medical device: lot #: b72295.Method: visual inspection, material analysis, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The screw was returned in 3 pieces: the main shank, the tulip head, and the head of the shank.Deformation was found on the shank.No relevant manufacturing issues were identified.Conclusion: per material analysis the screw have fractured ductilly due to applied torsional force.Screw hole preparation, under tapping, and patient bone quality are contributing factors.
Event or Problem Description
It was reported that a screw became bound in a patients bone and broke in the process of trying to remove it.In addition, a screwdriver also broke in the process of trying to remove the screw.

• Brand Name: 9.5X100 POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6993539
• Report Number: 3005525032-2017-00101
• Device Sequence Number: 1183981
• Product Code: KWP
• UDI-Device Identifier: 07613327351750
• UDI-Public: (01)07613327351750
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 02/07/2018

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 Model Number: 4826195100
• Device Catalogue Number: 4826195100
• Device Lot Number: B72295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1