MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 18MM PLATE SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 48554318

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Event Description

It was reported that; the silver screw broke upon insertion leaving the broken end in patient.It was reported that they were not able to remove it.It was also reported that the blue screw bent upon insertion.It was reported that lot numbers unknown, items removed from packaging to be sterilized in the set.It was reported that product reached patient; no apparent harm; probably inconvenient for patient and/or staff.

Manufacturer Narrative

Lot# a3y.Method: visual inspection; device history review; complaint history review; risk assessment; results: materials analysis found "the fractured screw was found to have torsional ductile overload due to an applied torsional force during implantation.The chemistry of each submitted screw was consistent with the chemistry specified on the print.No material or manufacturing defects were found.Conclusion: the probable root cause of the screw breakage and deformation is not tapping to the full length of the intended screw.

Event Description

It was reported that; the silver screw broke upon insertion leaving the broken end in patient.It was reported that they were not able to remove it.It was also reported that the blue screw bent upon insertion.It was reported that lot numbers unknown, items removed from packaging to be sterilized in the set.It was reported that product reached patient; no apparent harm; probably inconvenient for patient and/or staff.

• Brand Name: OASYS 3.5 X 18MM PLATE 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5664997
• MDR Text Key: 45794125
• Report Number: 0009617544-2016-00195
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371966
• UDI-Public: (01)04546540371966
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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
• Device Operator: No Information
• Device Catalogue Number: 48554318
• Device Lot Number: A3Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2013
• 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