MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON LATITUDE II CURETTE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	A11B
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and functional examination of the instrument confirmed the instrument shaft is broken at the score line.The device failed as intended by design.The score line is designed to separate when the physician usage exceeds a predetermined tensile value.Separation at the score line limits the amount of rotational force that can be applied to the distal end of the curette.This minimizes the likelihood of a device failure to occur, such as the bending or breaking of distal tip.The above observations are consistent with exceeding the design limits of the instrument.The curette has been autoclaved as the plastic purple handle has melted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product was not 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
Pre-operative diagnosis: primary osteoporosis type of fracture: compression fracture it was reported that intra-op, after the curette was inserted into the vertebral body, the angle did not change even when the lever was grasped.The curette was being used in accordance with the surgical technique.The tip of the curette did not move even when the surgeon was checking outside the patient¿s body.Hence, another curette was opened and was used to complete the procedure successfully.There was a delay of less than 60 minutes in the overall procedure due to this event.No patient complications were reported.When the curette was checked, it was found that a part of the curette had separated.

• Brand Name: KYPHON LATITUDE II CURETTE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9243341
• Report Number: 9612164-2019-04508
• Device Sequence Number: 305468
• Product Code: LXH
• UDI-Device Identifier: 00763000031909
• UDI-Public: 00763000031909
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 Catalogue Number: A11B
• Device Lot Number: 217223323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 10/27/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1