MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800307
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting product return.
Event or Problem Description
It was reported that during a neuro tumor removal procedure the irrigation sleeve of the straight tip melted.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully using an alternative device.
Additional Manufacturer Narrative
Additional information: upon receipt of product it was identified that the tip was broken.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a neuro tumor removal procedure the irrigation sleeve of the straight tip melted.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully using an alternative device.It was subsequently reported that the tip also broke.
Additional Manufacturer Narrative
Additional information: device evaluation: investigation results indicate that the sleeve melted due to inadequate use of irrigation.Investigation results indicate that the tip break was a result of prolonged running without irrigation and the heating associated with lack of irrigation caused a fatigue fracture.The ifu of handpieces and console associated with this device warns the user against this type of use: "always use sufficient irrigation flow.Failure to comply may result in excessive heat and potential burn injury." the quality investigation is complete.
Event or Problem Description
It was reported that during a neuro tumor removal procedure the irrigation sleeve of the straight tip melted.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully using an alternative device.It was subsequently reported that the tip also broke.

• Brand Name: STRAIGHT
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8888455
• Report Number: 0001811755-2019-02683
• Device Sequence Number: 2587129
• Product Code: LFL
• UDI-Device Identifier: 37613252026670
• UDI-Public: 37613252026670
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K010309
• 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,Followup
• Report Date (Section B): 10/18/2019

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: 05/01/2021
• Device Catalogue Number: 5450800307
• Device Lot Number: M0016947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/02/2019; 10/11/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5450850003,DISPOSABLETUBING&EXTENDER, S/N:UNKNOWN