MAUDE Adverse Event Report: STRYKER CORP. STRYKER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED); 2.3 MM TAPERED ROUTER

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

While using the stryker's footplate attachment (stryker ref# (b)(4) to hold the tapered rooter (stryker ref# (b)(4) to perform a craniotomy, attending surgeon commented that the tip of the router broke off into the patient's surgical site.Upon closing the skull, attending surgeon reexamined the patient's surgical site both before, during and after the use of c-arm ray to attempt to locate the lost tip of the router.Attending surgeon unable to locate under fluoro.Attending surgeon closed surgical site and sent patient to ct immediately following surgery to locate missing router tip.Ct identified location of missing router tip.Attending surgeon requested patient to go back to operating room to reopen the surgical site and retrieve missing router tip, attending surgeon successfully removed the tip of the router under fluoroscopy in the operating room, surgeon did not request for the found router tip to go to pathology.

• Brand Name: STRYKER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Type of Device: 2.3 MM TAPERED ROUTER
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 10448699
• MDR Text Key: 204450645
• Report Number: MW5096245
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR