MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS PLUS DRILL ASSY 2.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48565323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No anomalies were noted during a visual inspection of the instrument.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
I was reported that; during surgery, a lateral mass screw hole at c6 was attempted to be created using an adjustable drill guide and drill.The screw hole became bigger than expected because the drill felt blunt and it was needed to apply force.The surgery was completed with a recovery shot.The recovery shot was approached from the same entry point towards the cortical bone of the c6 / 7 articular surface, and a screw was implanted.There was a reported 30 minute surgical delay.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, risk assessment.Result: the reported event could not be confirmed as the device was reported to be in correct order after visual inspection.There were no reported anomalies with the drill.No lot# was provided so a manufacturing record review could not be performed.The cause of the event could not be determined.
Event or Problem Description
I was reported that; during surgery, a lateral mass screw hole at c6 was attempted to be created using an adjustable drill guide and drill.The screw hole became bigger than expected because the drill felt blunt and it was needed to apply force.The surgery was completed with a recovery shot.The recovery shot was approached from the same entry point towards the cortical bone of the c6 / 7 articular surface, and a screw was implanted.There was a reported 30 minute surgical delay.There are no reports of adverse health consequences to the patient.

• Brand Name: OASYS PLUS DRILL ASSY 2.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7277227
• Report Number: 0009617544-2018-00042
• Device Sequence Number: 16512954
• Product Code: LXH
• UDI-Device Identifier: 07613327271874
• UDI-Public: (01)07613327271874
• Combination Product (Y/N): N
• 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): 04/27/2018

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 Model Number: 48565323
• Device Catalogue Number: 48565323
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR