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	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
A company representative reported that three reflex hybrid quick turn insertion drivers deformed at the tip during use.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the first of three devices.
Additional Manufacturer Narrative
The device was discarded by the user and so evaluation could not be performed.Device history records and complaint history could not be reviewed as the lot was not provided.Complaint history was performed on the device catalogue number and no similar events were identified.The device had been used over one hundred times over the past three or more years.Bone quality of patient was reported to be hard.As reported by the field representative, the surgeon appeared to use complex maneuvers on the device during the procedure.Although a definitive root cause cannot be established with the information provided by the reporting physician, it is possible that extensive use, the age of the device, and the patient's hard bone could have contributed to the event.
Event or Problem Description
A company representative reported that three reflex hybrid quick turn insertion drivers deformed at the tip during use.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the first of three devices.

• 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: 11813060
• Report Number: 0009617544-2021-00083
• Device Sequence Number: 19639351
• Product Code: LXH
• UDI-Device Identifier: 07613327270945
• UDI-Public: 07613327270945
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/08/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1