MAUDE Adverse Event Report: ACUMED LLC 4.3MM X 30MM LOW PROFILE HEXALOBE SCREW

Model Number 3011-43030-S

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

While inserting a distal locking screw into the humeral shaft, the screw head broke off.It was initially lost in the soft tissues.The surgery was extended by 30 minutes and the incision enlarged to locate the screw head.

• Brand Name: 4.3MM X 30MM LOW PROFILE HEXALOBE SCREW
• Type of Device: SCREW
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass rd.; hillsboro OR 97124 943
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass rd.; hillsboro OR 97124 943
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass rd.; hillsboro, OR 97124-9432 ; 5035744547
• MDR Report Key: 4379854
• MDR Text Key: 21929640
• Report Number: 3025141-2014-00290
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2014

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 3011-43030-S
• Device Catalogue Number: 3011-43030-S
• Device Lot Number: 322392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• 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
• Patient Outcome(s): Required Intervention