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	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the "rotary head" (knob) fractured from a vlift inserter inner shaft.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
The following fields have been updated: d4, d9, h3.
Event or Problem Description
A company representative reported that the "rotary head" (knob) fractured from a vlift inserter inner shaft.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
A company representative reported that the "rotary head" (knob) fractured from a vlift inserter inner shaft.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Inspection of the returned device confirmed the fracture.The fracture surface shows characteristics of beach marks which indicate fatigue fracture among with torsional overload.The field representative confirmed the device was inserted at difficult angle during use, although the surgeon did not appear to use complex maneuvers or apply excessive force on the device.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.Based on the information provided and on visual inspection of the returned device the root cause of the reported event is application of excessive torsional force combined with material fatigue.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14342519
• Report Number: 0009617544-2022-00054
• Device Sequence Number: 5237244
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2022

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: 206066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 07/15/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/29/2022; 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown