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

Model Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that during intra-operative impaction the vlift expander broke.There were no adverse consequences to the patient.The procedure was completed successfully with a 20 minute surgical delay.
Event or Problem Description
It was reported that during intra-operative impaction the vlift expander broke.There were no adverse consequences to the patient.The procedure was completed successfully with a 20 minute surgical delay.
Additional Manufacturer Narrative
The device was not returned, therefore, an inspection was not performed.Images were provided and it appears the shaft is fractured off the knob as reported.Material analysis was performed on a similar device with the same failure mode and it was concluded that the shaft fractured away from the knob in a ductile overload mode likely caused by multiple directional forces applied onto the knob.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The device was manufactured in january 2012 and is 10 years old.The sales representative confirmed he had this device in his possession since 2012.The surgical vlift surgical technique states that: while rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.The plausible cause of the reported event is normal wear and tear due to device age.

• Brand Name: VLIFT EXPANDER
• 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: 12824246
• Report Number: 0009617544-2021-00221
• Device Sequence Number: 4425524
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 48300200
• Device Catalogue Number: 48300200
• Device Lot Number: 120048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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