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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a transsphenoidal procedure the tip of the device broke.It was also reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.A minor delay was reported of a few minutes to swap out the tip.
Additional Manufacturer Narrative
H6; the reported event, for tip breakage, was not confirmed as the device was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that during a transphenoidal procedure the tip of the device broke.It was also reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.A minor delay was reported of a few minutes to swap out the tip.

• 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: 10656943
• Report Number: 0001811755-2020-02640
• Device Sequence Number: 2705477
• Product Code: LFL
• UDI-Device Identifier: 37613327422529
• UDI-Public: 37613327422529
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/14/2020

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: 550025B302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1