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

Catalog Number	48770905B
Medical Device Problem Code	Material Deformation (2976)
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.
Additional Manufacturer Narrative
Brand name: long description corrected to aviator draw rod for rescue screwdriver catalog # corrected to 48770905b visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported device was confirmed to have a tip deformation.Manufacturing files were reviewed and no issues were found.The instrument was found to be manufactured approximately 8 years ago.Conclusion : based on visual inspection and the age of the device it is likely that the instrument deformed due to normal wear and tear.
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.

• 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: 8082997
• Report Number: 0009617544-2018-00270
• Device Sequence Number: 1437149
• 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): 01/08/2019

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: 48770905B
• Device Lot Number: 104757
• 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: 12/18/2018
• Initial Report FDA Received Date: 11/18/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1