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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vlift inside shaft broke intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Upon device return section d1 and d4 were updated to reflect the correct device information.Visual inspection: the shaft of the device is confirmed to be fractured off of the knob.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The lot was manufactured in april of 2015 therefore the instrument is over 6 years old.The surgeon did not appear to use complex maneuvers or excessive forces on the device during the procedure.It is unknown how many times this device has been used.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.Materia analysis was performed and a similar device with the same failure mode and concluded that the shaft fractured in a ductile overload mode likely caused by multiple directional forces applied onto the knob.Most likely cause of the reported event is normal wear due to device age.Application of unidirectional forces to the device may have also contributed to fracture.
Event or Problem Description
It was reported that during implant insertion the securing mechanism of a vlift expander fractured intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully using an alternatively available device.

• 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: 12044436
• Report Number: 0009617544-2021-00111
• Device Sequence Number: 4014063
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/27/2021

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 Model Number: 48300210
• Device Catalogue Number: 48300200
• Device Lot Number: 153769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1