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

Catalog Number	48770820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a quick turn screw driver broke inside of screw head during screw insertion.A surgical delay of 30 minute was reported.Broken fragments were retrieved and surgery was completed successfully.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon visual inspection.Manufacturing files were reviewed and no issues were found.The device was found to be over 8 years old.Additionally, it was reported that the instrument had been used 2-3 times per month over the last two years a conclusion: the probable root cause of the tip fracture is the age of the instrument (found to be over 8 years old).
Event or Problem Description
It was reported that the tip of a quick turn screw driver broke inside of screw head during screw insertion.A surgical delay of 30 minute was reported.Broken fragments were retrieved and surgery was completed successfully.No other adverse consequence to the patient was reported.

• 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: 8109707
• Report Number: 0009617544-2018-00278
• Device Sequence Number: 11185481
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: 07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: Health Professional
• Device Catalogue Number: 48770820
• Device Lot Number: 103994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1