MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT INSIDE SHAFT; 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	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift screwdriver inner shaft broke during intra-operative locking.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that a vlift screwdriver inner shaft broke during intra-operative locking.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Upon visual inspection, it was confirmed that the shaft of the draw rod is fractured off of the knob.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The device fractured during locking.The surgeon did not appear to be using any complicated maneuvers or excessive force on the device.The lot was manufactured in october of 2012 therefore the instrument is approximately 9 years old.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.Most likely cause of reported event is normal wear due to age.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11797680
• Report Number: 0009617544-2021-00079
• Device Sequence Number: 13708319
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/07/2021

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: 48300210
• Device Lot Number: 12A230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/11/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1