MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON V OSTEO INTRODUCER 13GA TROCAR/BEVEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	VPT13D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
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
It was reported that the patient underwent vertebroplasty at t11 due to hemangioma at t11/t12.During the surgery, the 13g trocar handle broke off the inner stylet, leaving the inner stylet (within the working cannula) and working cannula stuck in the patient¿s pedicle.After about 10 minutes of troubleshooting and counterforce from tech and nurses holding the patient down on the table, the surgeon was able to remove the needle from the patient.The doctor then decided to leave the t11 level untreated, and treated the t12 level with another kit to complete the case.The surgeon was unable to complete vertebroasty at t11 level due to trocar handle breaking off the working cannula and unable to access vertebral body.There was a delay of more than 60 minutes as a result in the procedure.No complication to the patient was reported as a result of procedure not being performed at t11.
Additional Manufacturer Narrative
Product analysis: the kit was returned with one handle separated from the metal tube/shaft.A visual inspection of the returned product revealed that the proximal flare and notch were missing, knurl looked light.Among the returned items, insert was included, but not the handle, no cement observed in cannula id.The proximal id was mostly/fully occluded with dried blood.Multiple crimped areas were observed, likely from secondary tool (e.G., kochers) to remove insert from vb(vertebral body).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 SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7272960
• Report Number: 1030489-2018-00233
• Device Sequence Number: 1133344
• Product Code: LXH
• UDI-Device Identifier: 00643169637481
• UDI-Public: 00643169637481
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2019
• Device Catalogue Number: VPT13D
• Device Lot Number: WI501738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR