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

Catalog Number	K08A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
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.
Event or Problem Description
It was reported that on (b)(6) 2017, intra op, the balloon was leaking from the "stop cock" connection.Due to the leak, the inflation device had air in the system.When trying to release the air, the reading of the device changed.When the surgeon was inflating the two balloons, they were inflating, but giving an incorrect reading.The result is that the bkp tamp balloon ruptured due to the pressure acceding the atm burst pressure.The ruptured balloons were removed.Surgeon was able to insert another bkp tray¿s balloon system.The case was completed with no other issues.No patient complication was reported as a result of this event.No fragments of the balloon remained inside the patient's body.
Additional Manufacturer Narrative
Product analysis: two inflation syringes and two ibts were returned.There was a substance dried inside the syringes and the ibts that is atypical of what is commonly seen on returns.The substance has hardened inside the returned items making it impossible to functionally check the items.Due to the condition of the returned a full analysis cannot be completed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel ; CH
• MDR Report Key: 6914013
• Report Number: 2953769-2017-00104
• Device Sequence Number: 1408868
• Product Code: HRX
• UDI-Device Identifier: 00643169103054
• UDI-Public: 00643169103054
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR