MAUDE Adverse Event Report: SKELETAL DYNAMICS, LLC. SKELETAL DYNAMICS SCREWDRIVER ; SCREW, FIXATION, BONE

Model Number PLS 2.5

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2020

Event Type  malfunction  

Event Description

During placement of a locking screw, the tip of a screwdriver broke flush into the head of x1 locking screw.Attempts were made to remove the broken screwdriver tip from the head of the locking screw.This could not be achieved as the tip was incarcerated within the head of the locking screw.

• Brand Name: SKELETAL DYNAMICS SCREWDRIVER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SKELETAL DYNAMICS, LLC.
• MDR Report Key: 9883277
• MDR Text Key: 185223624
• Report Number: MW5093937
• Device Sequence Number: 1
• Product Code: HWC
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLS 2.5
• Was Device Available for Evaluation?: No
• 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: 53 YR
• Patient Weight: 84