MAUDE Adverse Event Report: ACUMED LLC 1.5MM HEX DRIVER TIP, LOCKING GROOVE; DRIVER, FIXATION, BONE

Model Number 80-0728

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

A visual examination of the returned driver under magnification was performed.A torsional twist was found along the hex portion of the driver.Prior to breaking from an excessive twisting load (torsion) the driver tip may start to twist before the driver breaks.Hex tip twisting and breakage may occur when excessive force is applied to the driver during use to overcome increased resistance.

Event Description

During tightening of a screw with a driver, the tip of the driver broke off in the head of the screw.The tip was not able to be removed so it remains implanted in the patient.

• Brand Name: 1.5MM HEX DRIVER TIP, LOCKING GROOVE
• Type of Device: DRIVER, 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: 6416772
• MDR Text Key: 70314981
• Report Number: 3025141-2017-00043
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012655
• 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: 02/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 80-0728
• Device Catalogue Number: 80-0728
• Device Lot Number: 327839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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