MAUDE Adverse Event Report: BIOMET TRAUMA LAG SCREW INSERTER CONNECTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.  should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Event Description

It was reported that patient underwent an unknown procedure on an unknown date on the right side.During the procedure, an intramedullary nail was implanted.Additionally, it was reported that patient underwent total right knee arthroplasty at a later date.Subsequently, the patient underwent a revision procedure on (b)(6) 2015 due to infection.All components were removed and replaced with cement spacer molds.When the surgeon attempted to remove the intramedullary nail, the instrument fractured.The patient retained pieces of the instrument, and the nail and lag screw were unable to be removed.This resulted in a three hour delay.The cement spacers remained implanted, as the knee procedure could not be completed with the nail still implanted.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: "instruments, which have experienced extensive use or excessive force, are susceptible to fracture." lot number - 571500, manufacture date ¿ oct 24, 2014.Or the lot information could be: lot number - 508760, manufacture date ¿ sep 10, 2013.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04306 / 04575).

Event Description

It was reported that patient underwent an unknown procedure on an unknown date on the right side.During the procedure, an intramedullary nail was implanted.Additionally, it was reported that patient underwent total right knee arthroplasty at a later date.Subsequently, the patient underwent a revision procedure on (b)(6) 2015 due to infection.All components were removed and replaced with cement spacer molds.When the surgeon attempted to remove the intramedullary nail, the lag screw inserter and inserter connector fractured.The patient retained pieces of the instrument, and the nail and lag screw were unable to be removed.This resulted in a three hour delay.The cement spacers remained implanted, as the knee procedure could not be completed with the nail still implanted.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that patient underwent an unknown procedure on an unknown date on their right side.During the procedure, an intramedullary nail was implanted.Additionally, it was reported that patient underwent total right knee arthroplasty at a later date.Subsequently, the patient underwent a revision procedure on an unknown date due to infection.All components were removed and replaced with cement spacer molds.On (b)(6) 2015, the surgeon attempted to remove the intramedullary nail so that the cement spacers could be removed and the patient could be implanted with total knee components.When the surgeon attempted to remove the intramedullary nail, the lag screw inserter and inserter connecter fractured.The patient retained pieces of the instrument, and the nail and lag screw were unable to be removed.This resulted in a three hour delay.The cement spacers remained implanted, as the knee procedure could not be completed with the nail still implanted.

• Brand Name: LAG SCREW INSERTER CONNECTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5150522
• MDR Text Key: 28304948
• Report Number: 0001825034-2015-04306
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 11/30/2015

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 27953
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/09/2015; 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR