MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JGRKNT 1.0MM MINI 3-0 NDLS; FASTENER FIXATION DEVICE

Model Number N/A

Device Problems Difficult to Insert (1316); Sticking (1597)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/07/2014

Event Type  Injury  

Event Description

It was reported that patient underwent proximal interphalangeal joint procedure on (b)(6) 2014.During the procedure, the surgeon attempted to insert a juggerknot mini in the first hole drilled; however, the sleeve was stuck and juggerknot would not work.A second juggerknot mini of the same lot was attempted but was unsuccessful.The surgeon opened another juggerknot mini and attempted to insert; however, the sleeve did not work again and the bone fractured due to a hard insertion.The surgeon made another hole and attempted to insert another juggerknot mini; however, bone hole was broken due to the sleeve sticking.The surgeon stopped using the juggerknot mini and implanted bionic bone and a k-wire in the fractured part.There was a delay in the procedure of approximately 45 minutes due to the event.

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.Examination of returned device found no evidence of product non-conformance.During the evaluation, the sleeves were able to be manipulated by hand, therefore the root cause was determined to be due to surgeon preference.(b)(4).Has been addressed for the event.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-01673 & 06079 / 06080).

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTENER FIXATION DEVICE
• 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: 3923565
• MDR Text Key: 4667351
• Report Number: 0001825034-2014-06079
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2014

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 Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 608390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• 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): Hospitalization; Required Intervention