MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC 5X100MM RIGHT HUM TRIAL; TEMPLATE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported patient underwent a total elbow arthroplasty on (b)(6) 2014.During the procedure, it was noted the humeral trial was incorrectly marked.An implant of the same size as the trial was utilized to complete the procedure.

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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.Corrective action has been initiated to address the reported issue.

• Brand Name: DISC 5X100MM RIGHT HUM TRIAL
• Type of Device: TEMPLATE
• 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: 3966358
• MDR Text Key: 4752633
• Report Number: 0001825034-2014-06544
• Device Sequence Number: 1
• Product Code: HWT
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 414837
• Device Lot Number: 555011
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 07/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2011
• 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