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

Model Number 80-0728

Device Problems Break (1069); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2014

Event Type  Injury  

Event Description

During a surgery to implant a distal radius plate, the surgeon was using a driver to install a screw.When the surgeon tried to remove the driver from the screw, it was stuck.The driver was pulled vertically from the screw and the driver tip broke off in the screw.The surgeon was unable to get the driver tip from the screw head so it was left implanted in the patient.

Manufacturer Narrative

A visual examination under magnification was performed.An oblique fracture pattern was found before the radius where the shaft transitions from the hex portion of the driver to the round shaft portion of the driver.An oblique fracture pattern likely indicates a side loading (bending), which was applied to hex tip.The distance between the flats of the hex was measured.The distances were found to be.0590,.0585, and.0585 which is within the tolerance of.0587 +.003/-.005.Conclusions - a conclusion cannot be drawn based on the lack of information concerning the circumstances of this driver break.

• 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 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: 4352944
• MDR Text Key: 5139660
• Report Number: 3025141-2014-00284
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 284766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2012
• 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 Outcome(s): Required Intervention