MAUDE Adverse Event Report: BIOMET TRAUMA G-PIN 2.8BL 3.2PL 60CM 2PK; TRAUMA IMPLANT

Model Number N/A

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.The reported event was confirmed.Most likely evidence of a quality system deficiency.Investigation into the issue determined that this was an isolated incident.

Event Description

It was reported that during a right humeral nail procedure on (b)(6) 2015 it was found the package had two smooth tip guide pins instead of one smooth tip and one ball tip pin.Another package was used to complete the procedure without delay.

• Brand Name: G-PIN 2.8BL 3.2PL 60CM 2PK
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5419813
• MDR Text Key: 37791942
• Report Number: 0001825034-2016-00405
• Device Sequence Number: 1
• Product Code: HTY
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2016

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: 467265
• Device Lot Number: 662420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• 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