MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 20CM IQ APEX 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
Event or Problem Description
It was reported that during a transsphenoidal resection of pituitary tumor surgery, the blade/knife broke.It was also reported that charring occurred prior to the blade/knife breaking.It was further reported there were no delays and no adverse consequences as a result of this event.It was also reported that the procedure was completed successfully.This report addresses the instance of the blade/knife breaking.
Additional Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.A device history record (dhr) review was performed and all manufacturing specifications were met during the time of manufacture of this product.The product was evaluated by product engineering who concluded that the root cause of the part fracture is likely a combination of multiple factors.Excessive ¿on¿ time and insufficient ¿off¿ time which is outside the specified duty cycle detailed in the instruction for use(ifu).In addition, the very low irrigation setting (verified from the console logs) whilst ultrasonic power remained high led to increased temperatures in the part during use.Evidence of part heating was observed at the fracture site.
Event or Problem Description
It was reported that during a transsphenoidal resection of pituitary tumor surgery, the blade/knife broke.It was also reported that charring occurred prior to the blade/knife breaking.It was further reported there were no delays and no adverse consequences as a result of this event.It was also reported that the procedure was completed successfully.This report addresses the instance of the blade/knife breaking.

• Brand Name: 20CM IQ APEX 360
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10363353
• Report Number: 0001811755-2020-02065
• Device Sequence Number: 2888288
• Product Code: LFL
• UDI-Device Identifier: 37613327422529
• UDI-Public: 37613327422529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 04/01/2022
• Device Catalogue Number: 550025B302
• Device Lot Number: 20113017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1