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

Model Number 4826195100

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/05/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6993539
• MDR Text Key: 91301697
• Report Number: 3005525032-2017-00101
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 07613327351750
• UDI-Public: (01)07613327351750
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• 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