MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JUGGERKNOT 1.4MM SHRT W/NDLS; FASTENER, FIXATION

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/09/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a primary left medial collateral ligament repair with an ulna transposition transfer on (b)(6) 2014.During the procedure, the surgeon went to anchor the ligament and the anchor would not seat completely down.This occurred twice.The tips fractured off and had to be retrieved from the patient's wound, creating a twenty-five minute delay in the procedure.The patient was visually checked to make sure no fractured pieces remained.Another anchor was used to complete the procedure using a metal guide.

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.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.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-08396 / 08397).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Product likely failed due to misuse, by product being put through excessive force or bending overload, and/or not inspected for wear and disfigurement prior to use, which may have prevented the use of the instrument and its failure.As stated in the instructions for use: ¿do not use excessive force when inserting the device.Excessive force may cause damage to the device and/or adversely affect its performance¿the device can break or be damaged due to excessive activity or trauma.This could lead to failure requiring additional surgery and device removal.¿.

• Brand Name: JUGGERKNOT 1.4MM SHRT W/NDLS
• Type of Device: FASTENER, FIXATION
• 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: 4215739
• MDR Text Key: 4997913
• Report Number: 0001825034-2014-08396
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 912068
• Device Lot Number: 708990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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
• Patient Age: 43 YR