MAUDE Adverse Event Report: ARTHREX LOGISTIC CENTER ARTHREX DRILL BIT; BIT, DRILL

Model Number AR-1788J-CP

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2022

Event Type  Injury  

Event Description

Drill bit from arthrex broke off in the bone of the operative left foot.Could not retrieve out of the patient's foot.

• Brand Name: ARTHREX DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ARTHREX LOGISTIC CENTER; naples FL 34108
• MDR Report Key: 16339120
• MDR Text Key: 309326810
• Report Number: MW5114831
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1788J-CP
• Device Lot Number: 15036958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White