MAUDE Adverse Event Report: ZIMMER TRI STATE ZIMMER; ZMIIMER 2.0 DRILL BIT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2016

Event Type  Injury  

Event Description

A left patella repair was being conducted with an 2.0 drill bit broke off and a piece was contained in the patient's bone.At the time of this surgery a medical decision was made to leave the piece in the patient.However, on (b)(6) 2016 the patient came back in for a revision and the piece of the drill bit was removed.

• Brand Name: ZIMMER
• Type of Device: ZMIIMER 2.0 DRILL BIT
• Manufacturer (Section D): ZIMMER TRI STATE; 1001 briggs rd.; 275 mount laurel; NJ 08054
• MDR Report Key: 6148697
• MDR Text Key: 61624253
• Report Number: 6148697
• Device Sequence Number: 1
• Product Code: HTW
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2016
• Device Age: NA
• Event Location: Hospital
• 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): Hospitalization
• Patient Age: 50 YR