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

Model Number 80-0728

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Sticking (1597)

Patient Problem No Information (3190)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

While implanting a screw, the driver became stick in the screw and then broke off.The driver tip was left in the screw.

Manufacturer Narrative

A visual examination under magnification of the returned driver was performed.A torsional fracture pattern was found at the radius where the shaft transitions into the hex for the driver.A torsional fracture pattern likely indicates an excessive twisting load (torsion).No definitive conclusion can be drawn without additional information.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: 4566489
• MDR Text Key: 5553890
• Report Number: 3025141-2015-00042
• 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: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 80-0728
• Device Catalogue Number: 80-0728
• Device Lot Number: 286589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2012
• 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