MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN; AUTOBAHN EVO LOCKING WASHER, LEFT, SFX, TI

Model Number	1257.7111
Medical Device Problem Codes	Malposition of Device (2616); Inadequate User Interface (2958)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Insufficient Information (4580)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw was misplaced through an autobahn evo locking washer intra-operatively, and then removed from the patient.
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.It was reported that a screw was misplaced through an autobahn evo locking washer intra-operatively, and then removed from the patient.While inserting the distal, anterior 3.5mm screw into the plate, it deflected off its original drill path after bumping the post of the previously implanted total knee, creating an extreme angle which the screw head then passed thru the plate washer.The residents performing the procedure using the torque limiter to implant the screw and failed to notice the screw going thru the plate hole.The attending doctor returned to the room, removed the remaining screws for the washer and was able to retrieve the 3.5mm screw from the bone successfully.The issue reported describes the device being used with a total knee stem that bumped the screw and created an extreme angle at which the screw was inserted into the locking washer.The 3.5mm locking screw is intended to be used within a 40 degree cone of angulation through the 3.5 holes in the locking washer.Outside of this cone of angulation, the risk of screw pass through is increased.No determination could be made as to the cause of this reported issue.
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.It was reported that a screw was misplaced through an autobahn evo locking washer intra-operatively, and then removed from the patient.While inserting the distal, anterior 3.5mm screw into the plate, it deflected off its original drill path after bumping the post of the previously implanted total knee, creating an extreme angle which the screw head then passed thru the plate washer.The residents performing the procedure using the torque limiter to implant the screw and failed to notice the screw going thru the plate hole.The attending doctor returned to the room, removed the remaining screws for the washer and was able to retrieve the 3.5mm screw from the bone successfully.The issue reported describes the device being used with a total knee stem that bumped the screw and created an extreme angle at which the screw was inserted into the locking washer.The 3.5mm locking screw is intended to be used within a 40 degree cone of angulation through the 3.5 holes in the locking washer.Outside of this cone of angulation, the risk of screw pass through is increased.No determination could be made as to the cause of this reported issue.
Event or Problem Description
It was reported that a screw was misplaced through an autobahn evo locking washer intra-operatively, and then removed from the patient.

• Brand Name: AUTOBAHN
• Common Device Name: AUTOBAHN EVO LOCKING WASHER, LEFT, SFX, TI
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 19271696
• Report Number: 3004142400-2024-00078
• Device Sequence Number: 7034508
• Product Code: HSB
• UDI-Device Identifier: 00193982485733
• UDI-Public: 00193982485733
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: Health Professional
• Device Model Number: 1257.7111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic