MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the reflex hybrid revision driver draw rod was observed to be broken upon inspection.There was no procedure associated with this event.No surgical delay nor adverse consequences occurred.
Additional Manufacturer Narrative
A visual inspection was performed and the tip of the device was confirmed to be fractured.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.The reflex hybrid surgical technique and device ifu were reviewed: ¿ do not pull the screw out with only the inner shaft/draw rod.Note: ensure that the tip is fully expanded(draw rod tightened finger-tight) prior to attempting to remove the screw.Note: the revision driver must be axially aligned with the screw trajectory and fully seated in the screw head before inserting or tightening the inner shaft.Note: while the revision driver is attached to the screw, pivoting or angulation of the instrument must be avoided, as it can cause bending or breakage of the inner shaft.Tip: check the tip of the inner shaft/draw rod regularly to ensure that the threaded tip hasn¿t stripped.Instruments must be examined for wear or damage prior to surgery and after sterilization." the cause of the reported event is most likely normal wear due to device age as the device is approximately 6 years old.Excessive force applied in previous surgeries may have also contributed to the event.
Event or Problem Description
It was reported that the tip of the reflex hybrid revision driver draw rod was observed to be broken upon inspection.There was no procedure associated with this event.No surgical delay nor adverse consequences occurred.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12819951
• Report Number: 0009617544-2021-00220
• Device Sequence Number: 4869920
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/22/2022

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: 48511906B
• Device Catalogue Number: 48511906B
• Device Lot Number: 14H031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown