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

Catalog Number	800804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2016
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5514508
• Report Number: 3004024955-2016-00030
• Device Sequence Number: 601658
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2016

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: 800804
• Device Lot Number: 12181420-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 73