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

Catalog Number	5450-800-309
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tumor removal case, the tip broke 10 mins into use.The second tip used with the same handpiece also broke about 10 minutes into use.A third tip and a new handpiece was retrieved to complete the case with no further issues.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.The following day the account was testing the handpiece in use during the tip breaks and when a tip of a different lot number (on metal) was tested it cracked in a similar spot.This report is for the second tip that broke during the procedure.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a tumor removal case, the tip broke 10 mins into use.The second tip used with the same handpiece also broke about 10 minutes into use.A third tip and a new handpiece was retrieved to complete the case with no further issues.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.The following day the account was testing the handpiece in use during the tip breaks and when a tip of a different lot number (on metal) was tested it cracked in a similar spot.This report is for the second tip that broke during the procedure.

• Brand Name: STRAIGHT MICRO DIAMETER
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16410463
• Report Number: 3015967359-2023-00459
• Device Sequence Number: 3364676
• Product Code: LFL
• UDI-Device Identifier: 37613252026694
• UDI-Public: 37613252026694
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 06/30/2025
• Device Catalogue Number: 5450-800-309
• Device Lot Number: 1000494108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown