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

Catalog Number	800044
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while impacting the inserter, the metal cap that is welded to the distal tip became dislodged during insertion into the disc space.It subsequently turned the cage 90 degrees on the distal tip.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the acculif surgical technique indicates that 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.Instruments must be examined for wear or damage prior to surgery.The manufacturing history of the reported lot# revealed that the device was manufactured in (b)(6) 2014 and it is unknown how often/how many times the instrument has been used.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the plausible root cause can be due to the impaction of the inserter during the surgery was reported in addition to the normal wear and tear of the instrument.
Event or Problem Description
It was reported that; while impacting the inserter, the metal cap that is welded to the distal tip became dislodged during insertion into the disc space.It subsequently turned the cage 90 degrees on the distal tip.

• Brand Name: ACCULIF PL INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5654791
• Report Number: 3004024955-2016-00049
• Device Sequence Number: 171379
• Product Code: LXH
• UDI-Device Identifier: 07613327105926
• UDI-Public: (01)07613327105926
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

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: 800044
• Device Lot Number: 06121404-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 07/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1