MAUDE Adverse Event Report: STRYKER SPINE-FRANCE VBOSS SMALL CAGE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	33660700
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the inserter was not functional.The inner shaft was not linked to the dial.After that, the surgeon inserted the cage with a forceps.
Additional Manufacturer Narrative
The customer reported event of cage inserter jamming was confirmed via visual and functional inspections.Inspection of the jaws found deformation and wear on the instrument.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be more than 13 years old.A root cause of the event is normal wear and tear and extensive use of the instrument.
Event or Problem Description
It was reported that; during surgery, the inserter was not functional.The inner shaft was not linked to the dial.After that, the surgeon inserted the cage with a forceps.

• Brand Name: VBOSS SMALL CAGE INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6811849
• Report Number: 0009617544-2017-00329
• Device Sequence Number: 132322
• Product Code: LXH
• UDI-Device Identifier: 07613327262681
• UDI-Public: (01)07613327262681
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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 Model Number: 33660700
• Device Catalogue Number: 33660700
• Device Lot Number: 045807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1