MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	905103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tubing set frayed near the implant interface and the implant could not be expanded.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: this event was confirmed via visual inspection of the returned device.The peek portion of the tube is cut near the distal tip.Due to this cut, the device cannot hold pressure while attempting to expand the implant.Per surgical technique: ¿¿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, and disposal attention.¿¿ the risk file addresses tube set breakage.According to this document tube set may break or became damage due misalignment, applying excessive force during assembling to an inserter and during implant insertion.Conclusion: the possible root cause of the reported event is patient or user related -> misuse.
Event or Problem Description
It was reported that a tubing set frayed near the implant interface and the implant could not be expanded.

• Brand Name: ACCULIF TL TUBING SET
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5726066
• Report Number: 3004024955-2016-00062
• Device Sequence Number: 208136
• Product Code: MAX
• UDI-Device Identifier: 07613327067064
• UDI-Public: (01)07613327067064
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2016

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: No Information
• Device Catalogue Number: 905103
• Device Lot Number: 10141513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1