MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN PIN; PIN, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Fall (1848); Unspecified Infection (1930)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event please see associated reports:0001825034-2017-02504, 0001825034-2017-02505, 0001825034-2017-02506, 0001825034-2017-02507, 0001825034-2017-02508.

Event Description

One patient identified in a journal article reportedly experienced complications including a fall, wound dehiscence, and infection.Attempts to obtain additional information have been made; however, none has been provided and patient outcome is unknown.

• Brand Name: UNKNOWN PIN
• Type of Device: PIN, 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6487374
• MDR Text Key: 72627862
• Report Number: 0001825034-2017-02509
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• 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): Other