MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN LOCK SCREW; APPLIANCE, FIXATION

Model Number N/A

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Unstable (1667)

Patient Problem Pain (1994)

Event Date 05/07/2014

Event Type  Injury  

Event Description

It was reported patient underwent an open reduction, internal fixation procedure on (b)(6) 2014 due to left distal radius fracture.Subsequently, patient was revised on (b)(6) 2014 due to pain and instability.It was discovered that the proximal screws of the dvr crosslock distal radius plating system had back out.The surgeon stated it appeared the selected plate was not long enough.

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.Follow up attempts to obtain additional information pertaining to event details and product identification are in process.Should additional information be received, biomet will forward a supplemental report to the fda.The following sections could not be completed with the limited information provided.Category number - 131227112 or 131227114 or 131227116 or 131227118 or 131227120.Lot number and expiration date - unknown.Manufacture date ¿ unknown.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-05221 / 05222).

• Brand Name: UNKNOWN LOCK SCREW
• Type of Device: APPLIANCE, 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3850495
• MDR Text Key: 4407721
• Report Number: 0001825034-2014-05222
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• 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: 05/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• 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: UNKNOWN
• 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: 05/10/2014
• 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