MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HD 9CM STRAIGHT ATTACHMENT; DRILLING POWER TOOL ATTACHMENT, BASIC

Model Number 5407-120-050

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 04/04/2022

Event Type  Injury  

Event Description

The user facility reported the device disassembled during a procedure while in use inside the patient.The user facility noted they believe all of the components were retrieved from the surgical site when this occurred.After the event, the user facility advised the surgeon began having issues with brain swelling and bleeding (mannitol was given).The patient was transferred to ct while intubated and under anesthesia.No additional adverse consequences have been reported at this time.Attempts will be made to obtain additional information about the event.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Only an image was supplied.

Event Description

The user facility reported the device disassembled during a procedure while in use inside the patient.The user facility noted they believe all of the components were retrieved from the surgical site when this occurred.After the event, the user facility advised the surgeon began having issues with brain swelling and bleeding (mannitol was given).The patient was transferred to ct while intubated and under anesthesia.No additional adverse consequences were reported.

• Brand Name: HD 9CM STRAIGHT ATTACHMENT
• Type of Device: DRILLING POWER TOOL ATTACHMENT, BASIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 14575988
• MDR Text Key: 293288357
• Report Number: 3015967359-2022-01095
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096651
• UDI-Public: 07613327096651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5407-120-050
• Device Catalogue Number: 5407120050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 5407200000, MAESTRO AIR MOTOR, S/N UNKNOWN
• Patient Outcome(s): Other