MAUDE Adverse Event Report: DEPUY SYNTHES DEPUY; DRILL BIT 25MM

Model Number PF266186

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Deformity/ Disfigurement (2360); Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Orthopedic surgeon drilling out the screw for acetabulum and drill bit snapped off.Orthopedic surgeon was revising a hip using a drill bit with the drill and the drill bit broke off in pt's hip.After reviewing risk vs.Benefits, dr chose to leave drill bit in pt, due to risk outweighing the benefit.Intraoperative findings: the patient's proximal femoral anatomy was distorted and had a slight retroverted appearance.Stable implant fixation was noted.Complications: none.Implants: depuy revision corail stem with a high offset and a 1.5, 40mm ceramic head with a depuy gription cup measuring 62mm in diameter with a 10-degree elevated 4mm lateralized insert; (b)(6) 2021: patient was discharged home.

• Brand Name: DEPUY
• Type of Device: DRILL BIT 25MM
• Manufacturer (Section D): DEPUY SYNTHES ; 1302 wrights lane; east west chester PA 19380
• MDR Report Key: 11920533
• MDR Text Key: 254043818
• Report Number: 11920533
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PF266186
• Device Catalogue Number: 02274-25-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/20/2021
• 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 Age: 59 YR
• Patient Weight: 96