MAUDE Adverse Event Report: BIOMET TRAUMA US NANCY NAIL 450 25/10; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.This device is not manufactured by zimmer biomet us; however, this report is being filed as zimmer biomet in (b)(4), in manufactures a similar device under 510k number k993956.

Event Description

It is reported that during a trauma flexible nailing procedure, the nail tip fractured intra-operatively.All pieces were not able to be retrieved, as some of the nail remained stuck in the patient's bone.No further patient consequences have been reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It is reported that during a trauma flexible nailing procedure, the nail tip fractured intra-operatively while repositioning the fracture site.The fractured nail was able to be removed without issue, and a new nail was placed.No further patient consequences have been reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The distal nail tip fractured approximately 8mm from the distal end.The longer section¿s distal fracture surface has fracture artifacts that suggest a two-way bending fatigue fracture.The shorter nail section shows numerous gouges, scrapes, and signs of contact with hard objects.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: US NANCY NAIL 450 25/10
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6604417
• MDR Text Key: 76410419
• Report Number: 0001825034-2017-03501
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• 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,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: M21930
• Device Lot Number: 5230165
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: Not provided; 12/11/2017; 04/30/2018; 04/30/2018
• Supplement Dates FDA Received: 06/06/2017; 01/10/2018; 04/30/2018; 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2014
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 15 YR