MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PEG STANDARD 4.0X37.5MM; PLATE, FIXATION

Model Number N/A

Device Problems Difficult to Remove (1528); Fitting Problem (2183); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a left shoulder open reduction internal fixation procedure on (b)(6) 2014.During the procedure, five subchondral support pegs would not lock into the humeral head of the plate.Surgeon attempted to remove the plate but was unsuccessful as one of the subchondral support pegs would not disengage.The plate was reimplanted and five new support pegs were utilized to complete the procedure.A delay of an hour and a half occurred.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date & lot number - unknown; manufacture date ¿ unknown.This report is number 4 of 5 mdrs filed for the same event (reference 1825034-2014-06929 / 06933).

• Brand Name: PEG STANDARD 4.0X37.5MM
• Type of Device: PLATE, 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: 3994480
• MDR Text Key: 4819857
• Report Number: 0001825034-2014-06932
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: STP375
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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