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

Catalog Number	5450800307
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that the tip broke at the cutting end during a meningioma tumor surgery.It was also reported that the surgeon was able to safely remove the broken piece.It was further reported that there was a 5 minute delay as a result of this event.It was also reported there were no adverse consequences and the procedure was completed successfully using a replacement tip.
Additional Manufacturer Narrative
H6 & d10 the device was returned for investigation.Investigation results indicate that the fracture of the tip is likely the result of inadequate irrigation.The handpiece ifu associated with this device contains the following warning: " always provide adequate irrigation to the tip." the quality investigation is complete.
Event or Problem Description
It was reported that the tip broke at the cutting end during a meningioma tumor surgery.It was also reported that the surgeon was able to safely remove the broken piece.It was further reported that there was a 5 minute delay as a result of this event.It was also reported there were no adverse consequences and the procedure was completed successfully using a replacement tip.

• 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: 8956656
• Report Number: 0001811755-2019-02894
• Device Sequence Number: 2444437
• Product Code: LFL
• UDI-Device Identifier: 37613252026670
• UDI-Public: 37613252026670
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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 Catalogue Number: 5450800307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1