MAUDE Adverse Event Report: STRYKER SPINE-FRANCE VLIFT EXPANDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48300200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; there was kinked the tip of the inner cage when attempted to remove the inner cage from the expander after inserted cage.Then removed the expander, however there was remained the slim part of inner cage in patient.So it was removed the part out of patient body by manually.No adverse consequences.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history, risk assessment; result: the device was confirmed to have a fractured draw rod upon visual inspection of the returned device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the possible root causes of the reported event are normal wear and tear or instrument and multiple directional forces applied onto the knob.
Event or Problem Description
It was reported that; there was kinked the tip of the inner cage when attempted to remove the inner cage from the expander after inserted cage.Then removed the expander, however there was remained the slim part of inner cage in patient.So it was removed the part out of patient body by manually.No adverse consequences.

• Brand Name: VLIFT EXPANDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6130556
• Report Number: 0009617544-2016-00476
• Device Sequence Number: 1128993
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: (01)07613327266986
• Combination Product (Y/N): N
• 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): 01/27/2017

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: 48300200
• Device Lot Number: 142244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• 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