MAUDE Adverse Event Report: STRYKER SPINE-US INSERTER TRITANIUM TL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48930000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter handle moves but the implant does not.There were no adverse consequences resulting from this event.
Additional Manufacturer Narrative
Visual inspection showed that corrosion was found in the area of the locking mechanism, an indication of inadequate lubrication.Inadequate lubrication can possibly cause jamming with the locking mechanism over time.Functional inspection revealed that the device was able to be locked and unlocked.Reported event could not be duplicated.The tip was able to be moved after being unlocked.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A nonconformance was initiated after testing indicated that the reported event could be duplicated if the device was not properly lubricated.The root cause was determined to be misunderstanding on the part of the sales team on when and how the instruments are lubricated.A corrective action/preventative action was opened to further investigate and prevent recurrence.Surgical technique states: instruments must be examined for wear or damage prior to surgery.Thoroughly inspect the inserter tip and inserter shaft for any damage prior to use and do not use if any damage is evident to threads, rotating mechanism, etc.
Event or Problem Description
It was reported that the inserter handle moves but the implant does not.There were no adverse consequences resulting from this event.

• Brand Name: INSERTER TRITANIUM TL
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8732904
• Report Number: 3004024955-2019-00027
• Device Sequence Number: 2567933
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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 Catalogue Number: 48930000
• Device Lot Number: 17C625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 81096
• Patient Sequence Number: 1
• Patient Age: 61 YR