MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID QUICK TURN INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511820B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner shaft threads of a reflex hybrid quick turn insertion driver became disconnected from the rest of the tool.The threads remain lodged inside the screw.Surgery was successfully completed with a 3 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection confirmed that tip of the screwdriver is fractured and remain lodged inside the screw.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that the implantation angle was not difficult, no complex maneuver nor excessive force was used, the screw was self drilling and no tools were used to prepare screw hole, all in one guide was not used, the customer did not report bending the plate, bone quality is unknown.Per the surgical technique, while rare, 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, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.The root cause of the reported event is normal wear due to device age.
Event or Problem Description
It was reported that during screw insertion the threads of the inner shaft of a reflex hybrid quick turn insertion driver fractured off and remained lodged inside a screw.The screw was then removed from the plate.The procedure was completed successfully with a 3 minute surgical delay.No adverse consequences or medical intervention were reported.

• Brand Name: REFLEX HYBRID QUICK TURN INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12037292
• Report Number: 0009617544-2021-00109
• Device Sequence Number: 11136084
• Product Code: LXH
• UDI-Device Identifier: 07613327277012
• UDI-Public: 07613327277012
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/27/2021

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: 48511820B
• Device Catalogue Number: 48511820B
• Device Lot Number: 120676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1