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

Catalog Number	800307
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during tl funnel bone tamp impaction, the maluanle portion of tamp was damaged.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: it was reported that graft insertion cannula was packed tight with the bone graft and graft insertion pusher was impacted with a mallet in attempt to push graft through the device.The surgical technique states the 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.Additionally, placing incremental amounts of bone graft through the cannula allows for easier placement into the cage and disc space.Conclusion: the plausible root cause is user related.Specifically, excessive impact force applied to the instrument which may have caused device damage.
Event or Problem Description
It was reported that; during tl funnel bone tamp impaction, the maluanle portion of tamp was damaged.

• Brand Name: ACCULIF GRAFT INSERTION PUSHER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5537654
• Report Number: 3004024955-2016-00037
• Device Sequence Number: 11003850
• Product Code: LXH
• UDI-Device Identifier: 07613327105919
• UDI-Public: (01)07613327105919
• 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): 03/07/2016

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: 800307
• Device Lot Number: 07311413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1