MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS LLC 2.5MM DRILL; SCREW, FIXATION, BONE

Model Number	MDS111125150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Scrub tech noted the tip of the drill bit was broken after use in right shoulder.Tip of drill bit was visualized on c-arm imaging.Doctor removed both broken pieces from field.Imaging was taken and surgeon confirmed no foreign body remained in patient's wound.

• Brand Name: 2.5MM DRILL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS LLC; 7620 nw 25th street, unit 3; miami FL 33122
• MDR Report Key: 8775608
• Report Number: 8775608
• Device Sequence Number: 2539853
• Product Code: HWC
• UDI-Device Identifier: 10812269020487
• UDI-Public: (01)10812269020487
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/12/2019
• Report Date (Section F): 06/12/2019

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
• Operator of Device: No Information
• Device Model Number: MDS111125150
• Device Catalogue Number: MDS111125150
• Device Lot Number: BDLY1TS
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85
• Date Report Sent to FDA: 06/12/2019