MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6640004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 stenosis involved in t10-pelvis posterior fusion procedure.It was reported that during procedure, the solera rocker rod reducer broke when they tried to get it attached to a very lateral screw head.One of the tips broke straight off into one long piece.The broken piece and the rest of the instrument were retrieved from the patient successfully without patient harm.The t25 voyager ball ended driver was broken when they tried to advance the left l5 screw.The tip broke off into the screw head, they were able to retrieve the screwdriver tip from the patient.No part of the instrument remained in the patient.The patient had sclerotic bone at this level as noticed by the surgeon.There was delay in overall procedure time for 90 seconds.Product was utilized correctly according to the directions given in the ifu/labeling.There were no patient symptoms or complications reported as a result of this event.Patient is alive and no injury.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12075608
• Report Number: 1030489-2021-00852
• Device Sequence Number: 3564872
• Product Code: LXH
• UDI-Device Identifier: 00643169492509
• UDI-Public: 00643169492509
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 6640004
• Device Catalogue Number: 6640004
• Device Lot Number: NM18J002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR