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

Catalog Number	VPT13D
Medical Device Problem Codes	Material Separation (1562); Mechanical Jam (2983)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that intra-op, trocar got stuck in the vertebral body, possibly due to heavy malleting and denser than normal bone.Upon attempting to pull out trocar, the purple hub on superficial end ripped off from the trocar placed in the pedicle and vertebral body.At times, physician was pulling so hard on the needle that the patient was being lifted off of the table.Once the purple hub ripped off, the surgeon had to use vice grips and a mallet to remove the needle from patient to prevent an open spine surgery to remove.The doctor was sure that the bond between the hub and cannula became loose due to heavy malleting.The patient had hematoma at access site, possibly due to excessive pulling force on the trocar and pedicle.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the cannula was returned undamaged.There was cement inside the cannula shaft.It was unable to determine root cause of non-conformance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: osteoporotic vertebral compression fractures procedure involved: vertebroplasty at t5, t6, t7 and l2.Issue occurred when operating between t5 and t6.

• 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
• MDR Report Key: 9892527
• Report Number: 9612164-2020-01385
• Device Sequence Number: 886705
• Product Code: LXH
• UDI-Device Identifier: 00763000026820
• UDI-Public: 00763000026820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/30/2020

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: 11/30/2020
• Device Catalogue Number: VPT13D
• Device Lot Number: 216656426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 03/28/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR