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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screwdriver broke at the tip during bone screw insertion.Inner pull rod is intact.Replacement was available.
Event or Problem Description
It was reported that the screwdriver broke at the tip during bone screw insertion.Inner pull rod is intact.Replacement was available.
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 visually to have the distal tip fractured.The fragment was removed.No consequence to the patient was reported.No surgical delay was reported.Manufacturing files were reviewed and no anomalies were found.The instrument was revealed to be approximately 7 years old.A materials analysis report on a previous pi revealed that the hardness and material chemistry were in accordance with the print.Conclusion: the probable root cause of the tip fracture is the age of the instrument.

• 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: 7918092
• Report Number: 0009617544-2018-00235
• Device Sequence Number: 1914601
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: 07613327273045
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

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 Catalogue Number: 48770820
• Device Lot Number: 111517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1