MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR ARTHRODESIS NAIL 5 DEGREE COLLAR ASSEMBLY WITH LOCKING BOLTS; ROD, FIXATION

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 11/08/2016

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: loosening, migration and/or fracture of the implants can occur due to loss of fixation, trauma, misalignment, bone resorption, and/or excessive activity.

Event Description

Patient underwent revision procedure approximately three months post implantation due to screws backing out.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of device history records indicated that the devices were manufactured to specifications.As the returned product was able to assemble correctly when tested and no significant damage could be noted on the returned product, the alleged complaint could not be reproduced.The most likely cause of the screws at the collar becoming loose cannot be conclusively determined.

• Brand Name: MODULAR ARTHRODESIS NAIL 5 DEGREE COLLAR ASSEMBLY WITH LOCKING BOLTS
• Type of Device: ROD, 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: 6154567
• MDR Text Key: 61730566
• Report Number: 0001825034-2016-05049
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK042409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: CP260601
• Device Lot Number: 499460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2015
• 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