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

Model Number	48300210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during insertion of a cage, a vlift expander inner shaft fractured intra-operatively.The cage was left inside the patient partially expanded as an alternative device was not available.This attributed to a 15 minute surgical delay.On 12/03/2019, we were informed that the patient had undergone revision surgery to replace the device that was placed by this instrument.
Additional Manufacturer Narrative
Visual inspection of the returned device confirmed that the knob of the draw rod is fractured from the shaft.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.A review of product history identified no similar complaints for this lot.The device was manufactured in december 2015.From instruments general ifu, "the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order." the most likely root cause of reported event is normal wear due to age.
Event or Problem Description
It was reported that during insertion of a cage, a vlift expander inner shaft fractured intra-operatively.The cage was left inside the patient partially expanded as an alternative device was not available.This attributed to a 15 minute surgical delay.On 12/03/2019, we were informed that the patient had undergone revision surgery to replace the device that was placed by this instrument.

• 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: 10150808
• Report Number: 0009617544-2020-00086
• Device Sequence Number: 1800805
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48300210
• Device Catalogue Number: 48300200
• Device Lot Number: 157526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention