MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PHOENIX NAIL

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Konstantinos triantafillou, eric barcak, arturo villarreal, cory collinge, and edward perez.Proper distal placement of tibial nail improves rate of malalignment for distal tibia fractures.Orthop trauma 2017;31:e407¿e411.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 was reported in a journal article that overall malalignment in the coronal plane was 17.6%.There was a 2.9% (1/34) fracture malalignment rate when the nail was placed lateral to the center of the joint versus 27.5% (14/51) when placed medial to the center of the joint, with all occurring in valgus.There were 64 patients that met the inclusion criteria at a 48% misalignment rate, which was greatest when the nail was placed in the anterior quadrant.The study consisted of 24 phoenix nails while the remaining was competitor product.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN PHOENIX NAIL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7603934
• MDR Text Key: 111141207
• Report Number: 0001825034-2018-04016
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other