MAUDE Adverse Event Report: BRASSELER USA TWIST DRILL STANDARD; TWIST DRILL-STANDARD 1/16"

Catalog Number KM166-00-00

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/17/2017

Event Type  Injury  

Event Description

Pt had surgical repair of ruptured quadriceps tendon left side.A 1/16 drill bit broke off in the pt's patella during the surgical procedure.The broken bit was retrieved in its entirety during this surgical procedure.No harm to the pt.

• Brand Name: TWIST DRILL STANDARD
• Type of Device: TWIST DRILL-STANDARD 1/16"
• Manufacturer (Section D): BRASSELER USA
• MDR Report Key: 6732394
• MDR Text Key: 80816966
• Report Number: MW5071135
• Device Sequence Number: 1
• Product Code: DZA
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KM166-00-00
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 132