MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON LEGACY 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7480147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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 lumbar disc herniation involved in posterior thoracolumbar surgery/ internal fixation with screw rod procedure.It was reported that at intra-op, when to broke the set screw tail, the tool was broken in the set screw.After replacing the set screw with a new one, it was used normally.There was no fragments left in the patient's body.Product was never implanted, replaced with medtronic product.Event was associated with the patient.There were no patient symptoms or complications reported as a result of the event.There was no additional surgery/treatment performed as a result of the event.Patient is alive and no injury.On 2021-jan-19, received additional information that event occurred during implantation of screw in the patient.Tool/driver was replaced with another one during the procedure.On 2021-jan-28, received additional information that driver was discarded after surgery.Set screw did not break.Setscrew was unusable.

• Brand Name: CD HORIZON LEGACY 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11272452
• Report Number: 1030489-2021-00131
• Device Sequence Number: 584532
• Product Code: LXH
• UDI-Device Identifier: 00721902857089
• UDI-Public: 00721902857089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 7480147
• Device Catalogue Number: 7480147
• Device Lot Number: KH19E866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR