MAUDE Adverse Event Report: DEPUY SYNTHES INC. DEPUY SYNTHES 2.5MM DRILL BIT

Lot Number H698169

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/03/2018

Event Type  Injury  

Event Description

Pt in the operating room for an application of uniplanar external fixator spanning the left knee and orif of right bicondylar tibial plateau fracture with proximal tibial, lateral, and medial plates and screws.The tip of a depuy synthes drill bit, 2.5mm, broke off in the pt's right tibia.Surgeon elected to leave the piece in the tibia since it would do more harm to the pt to retrieve it.Depuy synthes sales rep aware.Per the surgeon, event disclosed to the pt.

• Brand Name: DEPUY SYNTHES 2.5MM DRILL BIT
• Type of Device: DRILL BIT
• Manufacturer (Section D): DEPUY SYNTHES INC.
• MDR Report Key: 8142162
• MDR Text Key: 129776469
• Report Number: MW5081931
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: H698169
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 42 YR
• Patient Weight: 98