MAUDE Adverse Event Report: BIOMET TRAUMA STD BRL 3-HOLE PLATE 135 DEG; DEVICE, FIXATION

Model Number N/A

Device Problem Device Packaging Compromised (2916)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Examination of returned device found no evidence of product non-conformance.During the evaluation, extensive damage was noted about the package, confirming the complaint.A conclusive root cause of the event could not be determined, but excessive handling during transportation is most likely a contributing factor.

Event Description

During a compression hip procedure, when the plate was opened it was noticed that the inner packaging was already opened.Another plate was used to complete the procedure.

• Brand Name: STD BRL 3-HOLE PLATE 135 DEG
• Type of Device: DEVICE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 5919255
• MDR Text Key: 53668454
• Report Number: 0001825034-2016-03411
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 2110-135-003
• Device Lot Number: 1736257
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2009
• 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