MAUDE Adverse Event Report: MEDTRONIC MEXICO EXPRESS II; ARTHROSCOPE

Model Number	KE102
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 ibts in a kyphoplasty for a vertebrae fracture at t10 and t12.It was reported that the hcp tried to curve the ibts by bending the inner guidewire.When forcing the ibts down the path created in the bone, the guidewire pushed forward and punctured the ibts.The ruptures occurred during inflation.There were no patient symptoms or complications as a result of the event.There was a delay in overall procedure time by approx.3 minutes.There was no in-patient hospitalization or prolongation of existing hospitalization necessary or treatment or additional surgery performed as a result of this event.The procedure was completed successfully with a new product.No further complications were reported/ anticipated.

• Brand Name: EXPRESS II
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 12538995
• Report Number: 9612164-2021-03707
• Device Sequence Number: 11782073
• Product Code: HRX
• UDI-Device Identifier: 00763000312015
• UDI-Public: 00763000312015
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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 Expiration Date: 05/17/2023
• Device Model Number: KE102
• Device Catalogue Number: KE102
• Device Lot Number: 222234784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 99