MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS OSTEO INTRODUCER SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	T34A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: device fragment in patient.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 the patient underwent sacroplasty at sacrum and iliac region.The patient had a very dense bone and was difficult to access; hence, the diamond tip introducer was hammered through the ilium and into the sacrum.Intra-op, when attempting to remove the cannula, it proved to be difficult.Thus, cannula was twisted back and forth while yanking, with the product still in place.Whilst pulling the diamond tip introducer along with the purple plastic, aspect of the working cannula broke off.The product was pulled out leaving the metal only working cannula protruding from the hip.The surgeon then grabbed hemostat and grabbed the protruding metal and began pulling and twisting the empty cannula.At this time, the metal cannula was crushed, and the metal was torn, which cut the surgeon¿s own hand.The surgeon tried unsuccessfully reintroducing the diamond tip introducer into the cannula to get a better grip.He tried once again grabbing it from a more distal aspect and ended up snapping it off beneath the skin.The cannula was reimaged, and it appeared to be in its original position within the sacrum and ilium, snapped off at the ilium cortex.The procedure was delayed due to this event.The broken fragment of the product remained retained in the bone.It is unknown whether there were any patient complications or not.

• Brand Name: KYPHON EXPRESS OSTEO INTRODUCER SYSTEM
• 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: 9367283
• Report Number: 9612164-2019-04869
• Device Sequence Number: 421135
• Product Code: LXH
• UDI-Device Identifier: 00763000025755
• UDI-Public: 00763000025755
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/23/2019

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: 04/12/2021
• Device Catalogue Number: T34A
• Device Lot Number: 217489007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/24/2019
• 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: 31 YR