MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON EXPRESS INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K15B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
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 was preoperatively diagnosed with vertebral compression fracture and underwent an unspecified surgery.During surgery, balloon could not be inflated.A leak in the shaft of bone tamp was found due to which the pressure could not build up.The procedure was then completed successfully with a new product.Product came in contact with the patient.There was an unknown delay as the result of the event.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis visual, functional and microscopic evaluation was performed on the returned product.Observation: the ibt was returned with a cut in the shaft located approximately 45mm from the tip.The cut is approximately 15mm long,.15mm wide, and appears to have been made from the outside as the depth appears to go deeper in the center of the cut.The cut appears to have been made by a relatively sharp item as the outer sheathing is cut clean, with some distortion noted on the edges of the cut on the inner shaft sleeve.The shaft of the ibt is bent just below the marker on the shaft.The inflatable or balloon portion of the ibt has dried media inside the tip.This indicates that some media was able to enter the balloon during an inflation attempt, but it appears that the tip may have never inflated.The cut is visible to the naked eye.Conclusion: it appears that the shaft of the ibt was cut at some point after being manufactured, the exact timing of the damaged could not be determined at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Patient underwent thoroco-lumbar vertebral augment and kyphoplasty at l1.Intra-op, the operating physician did not achieve pressure in the balloon.It was identified that there was a pin hole along the side of the catheter.There was no posterior cement leakage evidence.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 7127931
• Report Number: 2953769-2017-00123
• Device Sequence Number: 13989364
• Product Code: HRX
• UDI-Device Identifier: 00613994721266
• UDI-Public: 00613994721266
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• 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): 02/05/2018

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 Catalogue Number: K15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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