MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID QUICK TURN INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48511820B
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the draw rod tip for the screwdriver broke off in the screw after it was implanted.The surgeon attempted to unthread the draw rod but after he removed the driver he noticed the tip was broken and still threaded in the screw.He left the screw in the patient with the tip of the draw rod.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.The tip was confirmed fractured.Manufacturing files were reviewed and no anomalies were found.Manufacturing review revealed an instrument approximately 8 years old.The probable root cause is normal wear based on usage and instrument age.
Event or Problem Description
It was reported that the draw rod tip for the screwdriver broke off in the screw after it was implanted.The surgeon attempted to unthreaded the draw rod but after he removed the driver he noticed the tip was broken and still threaded in the screw.He left the screw in the patient with the tip of the draw rod.

• Brand Name: REFLEX HYBRID QUICK TURN INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6413211
• Report Number: 0009617544-2017-00100
• Device Sequence Number: 13590838
• Product Code: LXH
• UDI-Device Identifier: 07613327277012
• UDI-Public: (01)07613327277012
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/24/2017

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: 48511820B
• Device Lot Number: 091180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR