MAUDE Adverse Event Report: ACUMED LLC 1.5MM HEX DRIVER TIP, LOCKING GROOVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: DRIVER

Model Number 80-0728

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00060: screw.

Event Description

While implanting a 2.3mm distal screw into an aculoc plate, the driver tip broke in the screw head.The tip could not be removed and remains implanted.

• Brand Name: 1.5MM HEX DRIVER TIP, LOCKING GROOVE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: DRIVER
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9862303
• MDR Text Key: 187744163
• Report Number: 3025141-2020-00058
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-0728
• Device Catalogue Number: 80-0728
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• 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