MAUDE Adverse Event Report: ACUMED LLC 2.8MM QUICK RELEASE DRILL; DRILL, FIXATION, BONE

Model Number 80-0387

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2017

Event Type  malfunction  

Event Description

When drilling the hole for the last screw being inserted into an orthopedic plate during implantation, the drill broke off in the bone.The drill fragment remains implanted.

• Brand Name: 2.8MM QUICK RELEASE DRILL
• Type of Device: DRILL, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432
• MDR Report Key: 6536438
• MDR Text Key: 74412740
• Report Number: 3025141-2017-00083
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 80-0387
• Device Catalogue Number: 80-0387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR