MAUDE Adverse Event Report: ACUMED LLC 2.3MM X 16MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-T2316

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 05/30/2014

Event Type  Injury  

Event Description

During routine plate removal surgery, the driver tip broke when the surgeon was trying to remove distal 2.3mm screws.When the driver tip broke, the surgeon became frustrated and wound up breaking the bone while removing the plate with two screws still inserted in the plate.The break in the bone was filled with bone graft material.

Manufacturer Narrative

The driver that was used by the doctor is not the standard part used for this type plate.The driver used was cannulated while the driver that is normally used with this plate is a solid driver.The broken cannulated driver had a torsional fracture pattern at the break which likely indicates an excessive twisting load.This may occur when excessive force is applied to the driver to overcome increased resistance.A solid driver will be better able to withstand higher torque values than the cannulated driver.The two screws were still threaded in the locking holes of the plate when the parts were received.Using an in-house driver, the screws were able to be unthreaded as designed.The locking threads on the screws and the plate were intact and functioned properly.In general, the plate and screws showed wear consistent with being implanted and then being removed.This included bone growth on the threads and holes.Additionally, there was damage to the plate consistent with trying to pry it off the bone.The screws were damaged and bent and the head shows signs of wear, although both still functioned as designed.Additional mdrs associated with this event: mdr 3025141-2014-00159 driver mdr 3025141-2014-00160 plate mdr 3025141-2014-00162 screw 2.

• Brand Name: 2.3MM X 16MM LOCKING CORTICAL SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 943
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 943
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 3942317
• MDR Text Key: 15994922
• Report Number: 3025141-2014-00161
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CO-T2316
• Device Catalogue Number: CO-T2316
• Device Lot Number: 283690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention