MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON V OSTEO INTRODUCER 11GA TROCAR/BEVEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPT11D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
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 provider (hcp) via manufacturer representative regarding patient spinal therapy for compression fracture.It was reported that from interventional radiology that a trocar failed and got stuck in the patient and had to be removed.There was patient involved in the event and no further complications or symptoms were reported.Additional information was received via manufacturer representative that the reported product was broken and no fragments left inside the patient.The product came in contact with the patient.

• Brand Name: KYPHON V OSTEO INTRODUCER 11GA TROCAR/BEVEL
• 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: 12575827
• Report Number: 9612164-2021-03820
• Device Sequence Number: 16419235
• Product Code: LXH
• UDI-Device Identifier: 00763000026806
• UDI-Public: 00763000026806
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/05/2021

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: 10/11/2021
• Device Model Number: VPT11D
• Device Catalogue Number: VPT11D
• Device Lot Number: 218655105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1