MAUDE Adverse Event Report: ZIMMER, INC.; BIT, DRILL

Model Number 2318-20

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2013

Event Type  malfunction  

Event Description

During the surgical repair of right quadriceps injury, a sterile drill bit handled by the surgeon broke off at the surgical site.Radiology notified at the request of the surgeon.Item retrieved shortly thereafter.Confirmed by radiology.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER, INC.; 345 e. main st.; warsaw IN 46580
• MDR Report Key: 6092505
• MDR Text Key: 59590629
• Report Number: 6092505
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2318-20
• Device Catalogue Number: 2318-20
• Other Device ID Number: 2.0MM DIAMETER (0.079)
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR