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

Model Number	48511820
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tip of a reflex hybrid quick turn insertion driver bent while loading the screw on the back table during surgery.The procedure was successfully completed without delay and with no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection: tip of the device was confirmed to be slightly bent laterally.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.As the device was manufactured in 2012, it is likely that repeated use of the instrument during its service life weakened the material integrity at the tip, contributing to tip deformation.
Event or Problem Description
A physician reported that the tip of a reflex hybrid quick turn insertion driver bent while loading the screw on the back table during surgery.The procedure was successfully completed without delay and with no adverse consequence to the patient.

• Brand Name: REFLEX HYBRID QUICK TURN INSERTION DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11439981
• Report Number: 0009617544-2021-00035
• Device Sequence Number: 3523545
• Product Code: LXH
• UDI-Device Identifier: 07613327270945
• UDI-Public: 07613327270945
• 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): 06/25/2021

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: 48511820
• Device Catalogue Number: 48511820
• Device Lot Number: 125753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1