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

Model Number N/A

Device Problems Bent (1059); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

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.Date of event - unknow.N evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿bending or fracture of the implant.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04239 / 04240).

Event Description

It was reported that patient underwent and unknown procedure on an unknown date.During the procedure, two anchor insertors failed.The first inserter fractured.The tip of the second inserter bent, and the anchor pulled out of the handle.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation confirmed the complaint and found one inserter fractured at the plastic section under the handle and the other inserter has a bent tip and the anchor pulled out of the handle.Products likely failed due to misuse, by products not being used per instructions within surgical technique.

• Brand Name: JGRKNT 1.0MM MINI 3-0 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: 5138445
• MDR Text Key: 27908195
• Report Number: 0001825034-2015-04239
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 311020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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