MAUDE Adverse Event Report: LINVATEC CORPORATION LINVATEC DRILL; BIT, SURGICAL

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was noticed that while the surgeon was reaming the femoral head the tip of the drill bit was missing; it was caught on the guide wire and easily retrieved.A linvatec drill was being used at the time of the event.A trochanteric fixation nail advanced set was opened and instrumentation was removed from that set to complete the surgery.Routine x-rays confirmed that there were no fragments remaining in the patient.The fracture was successfully approximated and the patient's status was as expected.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LINVATEC DRILL
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): LINVATEC CORPORATION
• MDR Report Key: 17533486
• MDR Text Key: 321432138
• Report Number: MW5140390
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1