MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of draw rod broke off in screw while attempting to remove.Instrument has been used for 50+ surgery's, and over tightened by surgeon.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed upon visual inspection to have the tip fractured during surgery.No manufacturing issues were discovered.The probable root cause is overtightening as advised against in the surgical technique.
Event or Problem Description
It was reported that the tip of draw rod broke off in screw while attempting to remove.Instrument has been used for 50+ surgery's, and over tightened by surgeon.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6146210
• Report Number: 0009617544-2016-00482
• Device Sequence Number: 13637833
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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: 48511906B
• Device Lot Number: 109528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1