MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM NAIL RETRO 10.5MM X 360MM; ROD, FIXATION

Catalog Number 14-444236

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Concomitant medical devices: 14-442021 retro fem connecting bolt unknown; 14-442019 retrograde fem nl driver unknown.Foreign- (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03654.

Event Description

It was reported that during surgery when the physician tried to put a retrograde nail, the driver nose pulled out of the nail.The surgeon had to extract the nail as the thread of the bolt was short and hence resulted in a surgical delay of two hours.

Event Description

Upon reassessment of the reported event, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: FEM NAIL RETRO 10.5MM X 360MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10600395
• MDR Text Key: 208973813
• Report Number: 0001825034-2020-03653
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-444236
• Device Lot Number: 210200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1