MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR QUICK TURN SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48770820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the during an acdf c3-c6, the hex head of the screwdriver broke off while trying to advance the screw.All broken fragments were successfully retrieved.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The tip was confirmed to be fractured.The fragment was removed from the patient.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be approximately 8 years old.Conclusion: the probable root cause of the tip deformation is the age of the instrument.
Event or Problem Description
It was reported the during an acdf c3-c6, the hex head of the screwdriver broke off while trying to advance the screw.All broken fragments were successfully retrieved.There are no reports of adverse health consequences to the patient.

• Brand Name: AVIATOR QUICK TURN SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7361044
• Report Number: 0009617544-2018-00073
• Device Sequence Number: 19070679
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: (01)07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 48770820
• Device Catalogue Number: 48770820
• Device Lot Number: 103988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1