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

Catalog Number	48300200
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	01/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during surgery of a t5 corpectomy the screwdriver outer part was damaged while the cage was being inserted.A small part of the blue handle came off.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were found upon device history review.Expander handle fracture was confirmed via visual inspection.The age of the device was found to be 9 years old.Based on the age of the device and visual inspection, it is likely that the device handle chipped off due to normal wear and tear.
Event or Problem Description
It was reported that; during surgery of a t5 corpectomy the screwdriver outer part was damaged while the cage was being inserted.A small part of the blue handle came off.

• 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: 6326916
• Report Number: 0009617544-2017-00056
• Device Sequence Number: 11039162
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: (01)07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/28/2017

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: 081391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1