MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SCREWDRIVER HEX BALL END 3.5MM

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/30/2014

Event Type  Injury  

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation of components determined the root cause of the event was most likely due to misuse by instrument being put through excessive force or over torqued, and/or not inspected for wear and disfigurement which may have prevented the use of the instrument and its failure.

Event Description

It was reported that patient underwent a knee arthroplasty receiving a biomet knee system on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 2014 for an unknown reason.During the revision procedure, the tip of the screwdriver fractured inside the femoral screw as it was being tightened.Another femoral component and screw were used to complete the procedure; however, a delay greater than thirty minutes was encountered as a result.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.There are warnings in the package insert that state that this type of event can occur: under precautions: "surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture" this report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2014-01149 & 01150).

• Brand Name: SCREWDRIVER HEX BALL END 3.5MM
• Type of Device: SCREWDRIVER
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3649829
• MDR Text Key: 11770022
• Report Number: 0001825034-2014-01149
• Device Sequence Number: 1
• Product Code: HXX
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• 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: 32-467201
• Device Lot Number: 816100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention