MAUDE Adverse Event Report: DEPUY-SYNTHES QUICK COUPLING DRILL BIT

Catalog Number 310.19

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/11/2017

Event Type  Injury  

Event Description

Synthes catalog number 310.19 2 mm drill bit - retained foreign body due to a breakage of drill bit.Drill bit has been sequestered pending further investigation.

• Brand Name: QUICK COUPLING DRILL BIT
• Type of Device: QUICK COUPLING DRILL BIT
• Manufacturer (Section D): DEPUY-SYNTHES
• MDR Report Key: 6750654
• MDR Text Key: 81384881
• Report Number: MW5071268
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2017

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: No Information
• Device Catalogue Number: 310.19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2017
• 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