MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON® EXPRESS ¿ CURETTE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	A13A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using a curette in a balloon kyphoplasty (bkp) for a vertebral compression fracture at t11.It was reported that during the procedure, the surgeon encountered very hard bone.She attempted to inflate the balloons, but they had an abnormal inflation shape as well as very high balloon pressures.She removed the balloons and inserted a curette engaged at 90°.She gave it one turn and it immediately broke at the tip.She removed it and it was obviously broken along the end of the metal shaft, but the tip remained attached via the tether.They retrieved a new curette and had no issues using that one.The rest of the procedure continued as expected.There were no patient symptoms or complications as a result of this event.There was no a delay in overall procedure time, no in-patient hospitalization or prolongation of existing hospitalization necessary, and no treatment or additional surgery performed as a result of this event.No further complications were reported/ anticipated.
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.

• Brand Name: KYPHON® EXPRESS ¿ CURETTE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14082446
• Report Number: 9612164-2022-01405
• Device Sequence Number: 2097133
• Product Code: LXH
• UDI-Device Identifier: 00763000031848
• UDI-Public: 00763000031848
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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 Expiration Date: 10/04/2022
• Device Model Number: A13A
• Device Catalogue Number: A13A
• Device Lot Number: 222990610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/12/2022
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown