MAUDE Adverse Event Report: MEDTRONIC MEXICO OSTEOCOOL BONE ACCESS KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	OCN002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
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 the patient presented with the preoperative diagnosis of painful breast metastatic lesion at t11; and underwent a surgery.Intra-op, the plastic wing of the cannula separated from the cannula of the mapping instruments.The bone was extremely hard and a lot of heavy malleting was needed to gain trocar access in this osteoblastic breast lesion.The trocar was removed from the vertebral body with a coker clamp and mallet to gain leverage in order to get the cannula out of the patient.A new trocar was used in the same hole and the procedure was completed with no problems.No fragment of the broken product remained inside the patient.There was a delay of 15 minutes in overall procedure time due to this event.There were no patient complications as a result of this event.

• Brand Name: OSTEOCOOL BONE ACCESS KIT
• 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: 8639787
• Report Number: 9612164-2019-01950
• Device Sequence Number: 16716041
• Product Code: LXH
• UDI-Device Identifier: 00763000027049
• UDI-Public: 00763000027049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/24/2019

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: 10/26/2020
• Device Catalogue Number: OCN002
• Device Lot Number: 216474470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR