MAUDE Adverse Event Report: BIOMET ORTHOPEDICS HFN LAG SCREW 10.5MM X 80MM; FIXATION, ROD

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem Tissue Damage (2104)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.There are warnings in the package insert that state that this type of event can occur.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00774).

Event Description

It was reported during a hip fracture nail procedure on february 2, 2016, a lag screw interfered with the nail hole.The surgeon turned the set-screw but the lag screw could not be inserted into the nail hole.Another lag screw was used but it also interfered with the hole.Subsequently, another nail and the other lag screw were used to complete the procedure.Additional holes were drilled to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Visual inspection of the nail and lag screws shows some scratches on the inside of the hip nail where the lag screw inserts with some corresponding scratches on the lag screws.A conclusive root cause of the event could not be determined.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: HFN LAG SCREW 10.5MM X 80MM
• Type of Device: FIXATION, ROD
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 5485727
• MDR Text Key: 39863546
• Report Number: 0001825034-2016-00775
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 814510080
• Device Lot Number: DMHB9W
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2011
• 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): Required Intervention