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	04/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the expandable cage failed to attach to the tl inserter.
Additional Manufacturer Narrative
Catalog# 800804, lot# 06241404.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: a functional analysis was performed using sample acculif set, the device was confirmed to be functioning to spec.A secure attachment between the implant and the stainless steel connector (tubing) was obtained and no leakage was observed.An audible click was heard when rotating the blue knob to lock the cage onto the inserter.Conclusion: a functional analysis was performed using sample acculif set, the device was confirmed to be functioning to spec.No relevant issues were identified in the manufacturing records.
Event or Problem Description
It was reported that; the expandable cage failed to attach to the tl inserter.

• 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: 5666168
• Report Number: 3004024955-2016-00052
• Device Sequence Number: 18885129
• Product Code: LXH
• UDI-Device Identifier: 07613327105889
• UDI-Public: (01)07613327105889
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/28/2016

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: 06241404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1