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

Catalog Number	800804
Medical Device Problem Codes	Mechanical Problem (1384); Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; allegedly the inserter for a lumbar fusion surgery would not position properly and surgeon was unable to implant successfully.Back up implant was available.Additional information noted the following; the cage couldn't get to position properly because the locking mechanism on inserter broke and it was left in unlock causing surgeon to not be able to get force for cage to cross midline.Thus, we had to remove implant and use peek cages.
Additional Manufacturer Narrative
Visual inspection was performed and a small material damage was observed.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: plausible root cause is undetermined.
Event or Problem Description
It was reported that; allegedly the inserter for a lumbar fusion surgery would not position properly and surgeon was unable to implant successfully.Back up implant was available.Additional information noted the following; the cage couldn¿t get to position properly because the locking mechanism on inserter broke and it was left in unlock causing surgeon to not be able to get force for cage to cross midline.Thus, we had to remove implant and use peek cages.

• 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: 6655691
• Report Number: 3004024955-2017-00025
• Device Sequence Number: 197702
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 160010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR