MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; SCREWDRIVER

Model Number	5584332
Medical Device Problem Codes	Failure to Align (2522); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated summary- visual inspection confirmed the torx tip of the driver has been damaged.The torx edges have been rounded off/deformed.Functional inspection with a sample bone screw confirmed the driver was able to engage and thread into the screw without any issue.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with symptoms of oyl (ossification of yellow ligament) involved in crimping the screw stronger than usual.Levels implanted - t2-5.It was reported that intra-operatively, though the screw was attached to the screwdriver, there was too much looseness at the tip, and it could not be attached squarely.Product was used correctly according to the directions given in the ifu/labeling.Event was associated with the patient.Additional treatment/surgery performed to reinsert the screw.There was delay in overall procedure time for less than 60 minutes.No health damage in the patient was reported.On 2021-may-11, received additional information that s5 (rmas) was used for upper thoracic spine fixation.Even though the tip was aligned when connecting the screw to the cnrmas ls screwdriver (5584332), there is a lot of looseness, and it was difficult to attach it straight.Since there was a lot of looseness from the beginning, even though the sleeve was squeezed tightly with cleaning rags and was crimped, it was difficult to turn the sleeve and attach it straight.When the rmas screw was attached to the driver to insert it, it was difficult to insert the rmas screw because the axis of the bone screw of the rmas screw and the axis of the driver shaft were misaligned, and they could not be attached straightly.The driver and rmas screw were attached tightly, but it didn't improve.Although it was in such a state, it was said that it has managed to place the rmas screw.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12922569
• Report Number: 1030489-2021-01495
• Device Sequence Number: 5475971
• Product Code: HXX
• UDI-Device Identifier: 00643169086159
• UDI-Public: 00643169086159
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: 5584332
• Device Catalogue Number: 5584332
• Device Lot Number: CT12G009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male