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

Catalog Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, when surgeon attached a cage to the expander and strike its head with a plastic hammer, the base of the expander inner shaft broke.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a fractured draw rod upon visual inspection.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the plausible root cause of the reported event is multifactorial.
Event or Problem Description
It was reported that during the surgery, when surgeon attached a cage to the expander and strike its head with a plastic hammer, the base of the expander inner shaft broke.

• 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: 5490211
• Report Number: 0009617544-2016-00111
• Device Sequence Number: 1096566
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2016

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: 03/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR