MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 22MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48552322

Device Problems Break (1069); Detachment Of Device Component (1104); Disassembly (1168); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2017

Event Type  malfunction  

Event Description

It was reported that the head broke off the tulip screw during the case.The further reported that the construct had been locked down with the rod and the blocker.The surgeon then checked on x-ray and wanted to change the direction of the tulip head.When he tried to adjust it the head broke off the screw.The tulip head was removed with forceps and the surgeon was able to unwind the thread from the bone.No unintended metal was left in the patient.The bone was good quality and there were no other obvious issues.A new screw was inserted and the case was completed successfully with no lasting consequences for the patient.There was a 30 minute delay to surgery as a result of the reported event.

Manufacturer Narrative

Visual inspection, device history review, complaint history review, risk assessment.The screw tulip was confirmed separated based on visual examination.Manufacturing records for this product were reviewed and no anomalies were found.Potential root causes may be: user applies too much torsional force.User applies too much bending/cantilever force.

Event Description

It was reported that the head broke off the tulip screw during the case.The further reported that the construct had been locked down with the rod and the blocker.The surgeon then checked on x-ray and wanted to change the direction of the tulip head.When he tried to adjust it the head broke off the screw.The tulip head was removed with forceps and the surgeon was able to unwind the thread from the bone.No unintended metal was left in the patient.The bone was good quality and there were no other obvious issues.A new screw was inserted and the case was completed successfully with no lasting consequences for the patient.There was a 30 minute delay to surgery as a result of the reported event.

• Brand Name: OASYS 3.5 X 22MM POLYAXIAL SCREW
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6413754
• MDR Text Key: 70537294
• Report Number: 0009617544-2017-00099
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371720
• UDI-Public: (01)04546540371720
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48552322
• Device Lot Number: 09C061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1