MAUDE Adverse Event Report: STRYKER CORP. STRYKER SYSTEM 8 DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number STRYKER SYSTEM 8

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Drill bit broke inside patient while surgeon was drilling.Broken drill bit was extracted from patient's bone.Drill bit of drill broke during orif surgical procedure while surgeon was actively drilling.The broken drill bit piece lodged into the patient's bone.Surgeon was able to extract the broken piece.Xray confirmed successful removal.Pt was undergoing surgery for repair of femur - orif.

• Brand Name: STRYKER SYSTEM 8 DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORP. ; 15440 laguna canyon rd #150; irvine spectrum CA 92618
• MDR Report Key: 11759774
• MDR Text Key: 248778767
• Report Number: MW5101092
• Device Sequence Number: 1
• Product Code: HWE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STRYKER SYSTEM 8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR