MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 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	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that prior to a surgical procedure, the tip/sleeve was observed to be broken.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported, that prior to a surgical procedure.The tip/sleeve was observed, to be broken.It was also reported, that this event did not occur, during a surgical procedure.And there was no delay or adverse consequences as a result of this event.

• Brand Name: STRAIGHT MICRO DIAMETER
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• 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: 12099731
• Report Number: 3015967359-2021-01306
• Device Sequence Number: 14506807
• Product Code: LFL
• UDI-Device Identifier: 37613252026694
• UDI-Public: 37613252026694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 5450-800-309
• Device Lot Number: 1000405983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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