MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11CM IQ KNIFE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a lamnectomy surgery, the blade/knife broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a lamenectomy surgery, the blade/knife broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the product reported involved in this event was returned for evaluation.On receipt of the product the reported event of tip breakage was confirmed.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 ifu(instructions for use).In addition, the wear profile on the part indicates edge cutting may have generated side loads and torsional loads which promote part heating.Evidence of part heating was observed at the fracture site.The associated instructions for use(ifu) for this product contains the following warning; - ¿upon initial receipt and before each use, always inspect each component for damage.Do not use any equipment if damage is apparent or the inspection criteria are not met¿ - "do not strike the tip against a surgical instrument when applying ultrasonic power." - "do not apply excessive force or side loading on the tip or tip sleeve during handpiece use.Failure to comply may cause the handpiece and/or tip and tip sleeve to overheat.".

• Brand Name: 11CM IQ KNIFE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10149322
• Report Number: 0001811755-2020-01441
• Device Sequence Number: 2094013
• Product Code: LFL
• UDI-Device Identifier: 37613327422482
• UDI-Public: 37613327422482
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/24/2020

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: 08/01/2021
• Device Catalogue Number: 550025B107
• Device Lot Number: 19242037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1