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	10/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal tip of the quick turn driver broke off intra-op.The surgery was successfully completed using another driver.No adverse consequence to patient was reported.
Event or Problem Description
It was reported that the distal tip of the quick turn driver broke off intra-op.The surgery was successfully completed using another driver.No adverse consequence to patient was reported.
Additional Manufacturer Narrative
Correction: lot # corrected to 14g999.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 of returned product.Manufacturing files were reviewed and no anomalies were found.The instrument was revealed to be approximately 2.5 years old.A materials analysis report on a previous complaint revealed that the hardness and material chemistry were in accordance with the print.Conclusion: the probable root cause of the tip deformation is the age and usage 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: 8083001
• Report Number: 0009617544-2018-00271
• Device Sequence Number: 1501896
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: 07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/02/2019

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: 14G999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 11/18/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1