MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 20MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48555420
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implantation of a screw, it was very hard to screw it into the patient's bone.Ultimately, the screw sheared and broke on the shaft of the screw.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the stryker rep reported that the surgeon had prepped the hole prior to screw insertion and the patient had very hard bone quality.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable root cause is the patient's hard bone quality.
Event or Problem Description
It was reported that during an implantation of a screw, it was very hard to screw it into the patient's bone.Ultimately, the screw sheared and broke on the shaft of the screw.

• Brand Name: OASYS 4.0 X 20MM PA SCREW MEDIAL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5435330
• Report Number: 0009617544-2016-00056
• Device Sequence Number: 325010
• Product Code: KWP
• UDI-Device Identifier: 04546540469601
• UDI-Public: 04546540469601
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• 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): 01/19/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 48555420
• Device Lot Number: 137717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2016
• Supplement Report FDA Received Date: 04/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1