MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number 800804

Device Problems Cut In Material (2454); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2016

Event Type  malfunction  

Event Description

It was reported that upon trying to insert the cage, (after rotation of implant) the surgeon tried to expand the implant.She fill the syringe twice.There was no expansion.She then removed the implant and saw that the inserter had cut the tubing; replaced the tubing and re-inserted the implant, she then tried to expand the implant for the second time.Saline in the disc space was noticed.So she removed the implant again, and the inserter had cut the tubing again.At that time she made the decision to switch to anther type of interbody device.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the tubing sets were not returned and may have been discarded at the hospital.Dimensional analysis was performed on the similar device from same lot, and the instrument was found to be in compliance.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: a plausible root cause cannot be determined since additional information was not provided despite multiple attempts.

Event Description

It was reported that upon trying to insert the cage, (after rotation of implant) the surgeon tried to expand the implant.She fill the syringe twice.There was no expansion.She then removed the implant and saw that the inserter had cut the tubing; replaced the tubing and re-inserted the implant, she then tried to expand the implant for the second time.Saline in the disc space was noticed.So she removed the implant again, and the inserter had cut the tubing again.At that time she made the decision to switch to anther type of interbody device.

• Brand Name: ACCULIF TL INSERTION HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5514508
• MDR Text Key: 41033180
• Report Number: 3004024955-2016-00030
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 800804
• Device Lot Number: 12181420-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 73