MAUDE Adverse Event Report: BIOMET TRAUMA HFN LAG SCREW 10.5MM X 85MM; ROD, FIXATION

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.Review of the device confirmed the reported condition.Root cause of the event was most likely attributed to an isolated human error.Further investigation was initiated to address the reported issue.It was deemed no further actions necessary.

Event Description

During a hip fracture nailing procedure, it was found the inner packaging of the lag screw was not sterile.

• Brand Name: HFN LAG SCREW 10.5MM X 85MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5637921
• MDR Text Key: 44673434
• Report Number: 0001825034-2016-01492
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2016

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 814510085
• Device Lot Number: SE1213285F
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other