MAUDE Adverse Event Report: SYNTHES (USA) PRODUCTS LLC SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM SET MINI QUICK COUPLING (03.130.302); BIT, DRILL

Device Problem Break (1069)

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

Event Date 03/13/2020

Event Type  malfunction  

Event Description

Broken drill bit during surgery.

• Brand Name: SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM SET MINI QUICK COUPLING (03.130.302)
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES (USA) PRODUCTS LLC
• MDR Report Key: 9986633
• MDR Text Key: 188868667
• Report Number: MW5094213
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR