MAUDE Adverse Event Report: ACUMED LLC; SCREW, FIXATION, BONE

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

Patient Problem No Information (3190)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

During sugery, a screw was being inserted into the plate when the driver tip became stuck in the screw head.The surgeon moved the driver right and left in an attempt to dislodge the it from the screw.The tip of the driver broke off in the screw head.The surgeon decided to leave the broken tip in the screw head inside the patient.

• 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: 4186434
• MDR Text Key: 5020662
• Report Number: 3025141-2014-00257
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1