MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL INSERTER GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Supplemental information will be provided once the complaint investigation is completed.
Event or Problem Description
It is reported that during the procedure while putting in the cage and blades, the draw rod broke inside the cage when the surgeon tried to disengage the draw rod.Another instrument was used to remove the rod.There were no fragments, no adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.The customer reported event of tip fracture was confirmed via visual inspection.The fracture pattern and shear lip indicate that the device fractured in cantilever overload.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device likely fractured via overloading.
Event or Problem Description
It is reported that during the procedure while putting in the cage and blades, the draw rod broke inside the cage when the surgeon tried to disengage the draw rod.Another instrument was used to remove the rod.There were no fragments, no adverse consequences to the patient is reported.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7287470
• Report Number: 0009617544-2018-00051
• Device Sequence Number: 1211977
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: (01)07613327273496
• Combination Product (Y/N): N
• 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): 07/26/2018

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 Model Number: 48921100
• Device Catalogue Number: 48921100
• Device Lot Number: 143459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1