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 Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent revision surgery to remove a plate and put a new one on with rescue screws.When putting in rescue screws with the new plate, the tip of the retaining driver broke off and was unusable.All fragments were retrieved and the procedure was successfully completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence with the sales representative, as well as visual inspection of the returned device.No delay was reported, and the fragment was removed.The representative reported that the instrument had been used successfully 100 times.Manufacturing files were reviewed and no anomalies were found.The instrument was revealed to be approximately 8 years old.The probable root cause of the tip deformation is the age of the instrument.
Event or Problem Description
It was reported that a patient underwent revision surgery to remove a plate and put a new one on with rescue screws.When putting in rescue screws with the new plate, the tip of the retaining driver broke off and was unusable.All fragments were retrieved and the procedure was successfully completed with no adverse 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: 7572732
• Report Number: 0009617544-2018-00131
• Device Sequence Number: 2063305
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: (01)07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 08/26/2018

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: Health Professional
• Device Model Number: 48770820
• Device Catalogue Number: 48770820
• Device Lot Number: 103987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1