MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON V¿ OSTEO INTRODUCER® 13GA TROCAR/BEVEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPT13D
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
Event or Problem Description
Information was received from a regulatory body regarding a device used for vertebroplasty procedure.It was reported that the hub of vertebroplasty needle fractured from the body of the needle.Needle was successfully removed.No patient symptoms were reported.No further complications were reported regarding the event.
Additional Manufacturer Narrative
Report source: this complaint was reported via medwatch# (b)(4).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 V¿ OSTEO INTRODUCER® 13GA TROCAR/BEVEL
• 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: 13925922
• Report Number: 9612164-2022-01188
• Device Sequence Number: 12325138
• Product Code: LXH
• UDI-Device Identifier: 00763000311872
• UDI-Public: 00763000311872
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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: 11/13/2021
• Device Model Number: VPT13D
• Device Catalogue Number: VPT13D
• Device Lot Number: 218856893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/28/2022
• Date Device Manufactured: 11/13/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 112 KG