MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR QUICK TURN SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48770820
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the quick turn screw driver broke off during screw insertion.The surgeon was not using the instrument outside of its indicated usage.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Manufacturing files were reviewed and no anomalies were found.Manufacturing review revealed the instrument to be over 6 years old, the probable root cause of the tip fracture is normal wear.
Event or Problem Description
It was reported that the tip of the quick turn screw driver broke off during screw insertion.The surgeon was not using the instrument outside of its indicated usage.

• Brand Name: AVIATOR QUICK TURN SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6287691
• Report Number: 0009617544-2017-00040
• Device Sequence Number: 1518067
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: (01)07613327273045
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48770820
• Device Lot Number: 103995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention