MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER DRILL BIT BIT, DRILL

Model Number DRILL, AO. 04.2X340 #1806-420

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2019

Event Type  Injury  

Event Description

Pt in operating room for fixation of left periprosthetic distal femur fracture. When the surgeon was attempting to place the oblique screw, he noted that the pt's knee arthroplasty blocked the trajectory of the drill bit. The drill bit fractured upon attempting to pass the knee arthroplasty. It was removed, and the fragment of the drill bit was able to be retained and removed from the knee. Surgery proceeded without further incident. No harm to pt. Fda safety report id# (b)(4).

• Brand Name: STRYKER DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 8869326
• MDR Text Key: 153786799
• Report Number: MW5088862
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: NO INFORMATION
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/06/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: DRILL, AO. 04.2X340 #1806-420
• Device LOT Number: K058BAA
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/06/2019 Patient Sequence Number: 1