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

Model Number 48558524

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

It was reported that; the surgeon inserted a screw and decided to take it out because he didn't like the placement of the screw.When he tried to use the driver to remove the screw, the driver would not engage the inner nipple of the screw head because the inner nipple was stripped.He then inserted a rod and blocker and tried to "helicopter" the screw out, but the screw head broke off.He had to get a set of vice grips and use them to turn the screw to remove.After the case, the rep checked the drivers, and they are not stripped.The surgery was delayed about an hour.No other adverse consequences.

Manufacturer Narrative

Manufacturing records for this product were not reviewed because no parts or lot were provided.Device inspection was not performed because the device was returned.The root cause is not determined.

Event Description

It was reported that; the surgeon inserted a screw and decided to take it out because he didn't like the placement of the screw.When he tried to use the driver to remove the screw, the driver would not engage the inner nipple of the screw head because the inner nipple was stripped.He then inserted a rod and blocker and tried to "helicopter" the screw out, but the screw head broke off.He had to get a set of vice grips and use them to turn the screw to remove.After the case, the rep checked the drivers, and they are not stripped.The surgery was delayed about an hour.No other adverse consequences.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6858880
• MDR Text Key: 86105056
• Report Number: 0009617544-2017-00354
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540596437
• UDI-Public: (01)04546540596437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142741
• 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: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48558524
• Device Catalogue Number: 48558524
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR