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

Model Number	48300210
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative placement of a cage, the vlift inside shaft was damaged and could not be used.Additional information is being gathered at this time.
Event or Problem Description
It was reported that during intra-operative placement of a cage, the vlift inside shaft was damaged and could not be used.
Additional Manufacturer Narrative
Product inspection was not performed as no product was returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Limited information regarding the event was made available to stryker.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.
Additional Manufacturer Narrative
Correction: d9 / h3, h6.Additional data: d4 , h4.H6 codes have been corrected and updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
It was reported that during intra-operative placement of a cage, the vlift inside shaft was damaged and could not be used.

• 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: 14349815
• Report Number: 0009617544-2022-00055
• Device Sequence Number: 4143120
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022

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: 190550
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 11/29/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 08/18/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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