MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48770905B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was trying to unscrew the draw rod from the screw, the threads on draw rod broke off.The broken fragment remained in the screw, which remains implanted in the patient.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Lot # 152425.Result: device was confirmed to have its tip fractured as reported.The tip remained in the screw which was left in the patient.No adverse consequences were reported at this time.Manufacturing history was reviewed and no issues were identified.The device was used 100s of times and the device was found to be about 3 years old at the time of the event.The instruments ifu states that the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.The most likely root cause is normal wear and tear due to the device's extended use.
Event or Problem Description
It was reported that when the surgeon was trying to unscrew the draw rod from the screw, the threads on draw rod broke off.The broken fragment remained in the screw, which remains implanted in the patient.There are no reports of adverse consequences to the patient.

• Brand Name: AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7430697
• Report Number: 0009617544-2018-00082
• Device Sequence Number: 16411005
• Product Code: LXH
• UDI-Device Identifier: 07613327276886
• UDI-Public: (01)07613327276886
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: No Information
• Device Model Number: 48770905B
• Device Catalogue Number: 48770905B
• Device Lot Number: 152425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1