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

Catalog Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the top part of expander was broken intra-op.All broken fragments were retrieved.The surgery was completed successfully.No adverse consequences to the patient was reported.
Event or Problem Description
It was reported that the top part of expander was broken intra-op.All broken fragments were retrieved.The surgery was completed successfully.No adverse consequences to the patient was reported.
Additional Manufacturer Narrative
Method: visual inspection, material analysis (similar complaint device), product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed 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.A materials analysis performed on previous similar complaint determined that the shaft fractured away from the knob in a ductile overload mode likely caused by multiple directional forces applied onto the knob.The hardness and material were as specified on the print.No material or manufacturing defects were found.It was also reported that the instrument was impacted during use and instrument has been used about 120 times in last 5 years.Conclusion: based on the provided information and the age of the device, the plausible root cause of the reported event is normal wear and tear.

• Brand Name: VLIFT EXPANDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8114477
• Report Number: 0009617544-2018-00281
• Device Sequence Number: 1244308
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: Health Professional
• Device Catalogue Number: 48300200
• Device Lot Number: 12E318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 78